http://www.newscientistjobs.com/jobsNew Scientist Jobshttp://www.newscientistjobs.com/jobs/job/quality-associate-contract-republic-of-ireland-200642716.htmFri, 20 Nov 2009 13:13:06 +0000195730Quality Associate 12 Month Rolling Contract My client is a pharmaceutical company based in Dublin and they are seeking a Pharmaceutical Quality Associate whos remit will be to evaluate the quality aspects of new applications for human medicinal products with the IMB and variations to/renewal of existing market authorisations. Responsibilities: • In conjunction with the QM, local Regulatory Advisor and local Medical Advisor, ensure that the sales and marketing element of the company is compliant with all IPHA, IMB and corporate quality requirements • Update and where necessary write SOPs to act as guidance for the affiliate to ensure that we are compliant to quality guidelines • Devise and implement a process map for all current quality systems in the affiliate and update this as new systems are added • Hold monthly compliance meetings to review status of quality adherence in the affiliate and to identify potential areas for improvement • Carry out audits of quality systems locally are specific intervals to ensure that they are effective and to take corrective action where deviations or failures occur in the quality system (CAPAs) • Train all staff members on relevant areas of quality to their function as outlined in the training manualsMaintains all quality documents and records in an up to date manner • Represents the local affiliate to the IMB and UCB Corporate in conjunction with the GM and QM on all matters relating to quality • Updates and implements elements of the local Risk Management Plan • Liaises with the Pharmacovigilence and Medical Information divisions to ensure that all reports are completed for the affiliate. • Act as a lead on quality matters in the local affiliate and with the GM and QM to set a standard for all staff Experience and Qualifications: - 2+ years previous experience in managing quality systems is essential with preference given to those that have worked in quality management in a sales and marketing unit of a pharmaceutical company. - A degree in science or ideally a higher qualification is essential. ************************************************************** For Immediate Consideration Please Apply Online Now If you would like further information before applying please contact: Brian Christensen BA(Mod.)MedChem on +353 1 685 4747 Your details will not be passed to a Third Party without your express Prior Consent. View our Privacy Policy *************************************************************** Life Science Recruitment | http://lifescience.ie Life Science Recruitment is Ireland’s foremost specialist scientific and healthcare recruitment agency. We specialize in scientific, pharmaceutical, biotechnology, chemistry, quality management, clinical research, medical, allied healthcare, regulatory affairs, engineering, pharmacy and research jobs in Ireland. Check out our specialist websites now to view our latest jobs – choose your area of interest… lifescience.ie * pharmaceutical.ie * alliedhealth.ie * clinicalresearch.ie * scientificjobs.ie * medicaldevice.ie * biopharmaceutical.ie http://www.newscientistjobs.com/jobs/job/technical-director-north-west-200644690.htmFri, 20 Nov 2009 09:55:19 +0000195187Leading contact manufacturer of Health and Beauty Products in Europe. As a member of the senior management team, this role reports to the Managing Director and through functional managers assumes responsibility for product development, quality control and quality assurance. Responsibilities include: - Manage the introduction and registration of products - Keep abreast of and advise on marketplace trends and legislation in order to identify new product opportunities - Provide solid and commercially sound technical advice to the Sales function - Provide operations support in respect of formulation and process development - manage the QA/QV functions The candidate will: - Ideally have a degree and be currently operating in the food supplements, health care or food industry in a product development, formulation development or regulatory role. - Have an understanding of the legislative framework - Have a keen interest in new product concepts and formulation development - Be commercially and financially aware, with the skills to bridge the gap between the technical and commercial functions - Have worked in or managed a quality control function including experience of method development Reed Specialist Recruitment Limited is an employment agency and employment business. http://www.newscientistjobs.com/jobs/job/quality-and-product-development-executive-republic-of-ireland-200644136.htmThu, 19 Nov 2009 15:16:43 +0000195421Quality and Product Development Executive Responsibilities: •Updating and enforcing the company quality system (to ISO9001 standard) •New product development •Day-to-day management of HACCP system and management of finished product testing •Organisation of logistics for overseas shipments •Potential to take managerial role within the company Required Characteristics: •3-5 years experience in quality, chemistry or microbiology in a production environment. •Degree qualified (Science), preferably in Chemistry •Knowledge of GMP, GHP and GLP. Ability to work on own initiative. •Knowledge of Microsoft Word, Excel, Powerpoint, Outlook. •Full clean drivers licence. •Good medical history. ************************************************************** For Immediate Consideration Please Apply Online Now If you would like further information before applying please contact: Brian Christensen BA(Mod.)MedChem, on +353 1 685 4747 Your details will not be passed to a Third Party without your express Prior Consent. View our Privacy Policy *************************************************************** Life Science Recruitment | http://lifescience.ie http://www.newscientistjobs.com/jobs/job/health-and-safety-manager-ehs-ehs-hs-manager-south-east-200642618.htmWed, 18 Nov 2009 12:43:12 +0000190733Health and Safety Manager (EH&S EHS/ H&S Manager) c£25-40k Ref: AF/015137 An Environmental Health and Safety Manager (EH&S, H&S) is urgently required to ensure the company operates in a safe and legally compliant manner and drive the establishment of robust ESH systems. Key Responsibilities • Create and develop management systems for Environment, Health and Safety to enhance performance across the site • Build and develop strong relationships at all levels and in all areas of the business • Maintain excellent working relations with all inspectors from the Environment Agency, HSE and any other relevant body • Manage ESH budget assigned • Establish and monitor COSHH requirements • Manage effective ESH training programme • Participate and establish drive to behaviour based safety programme Environment: • Engage in continuous improvement programme to minimise waste streams • Ensure Hazardous wastes are handled in compliance with regulations • Carry out Duty of care audits on disposal sites • Review alternative waste disposal outlets • Handle complaints from neighbours, odour noise etc Health • Occupational Health program management • Manage COSHH programme evaluation and corrective actions • Ensure Manual Handling compliance • Support Operations team on emergency response issues Inspections and audits • Manage inspection and audit programme • Set up inspection topics • Co-ordinate Corporate audits • Manage external audits Skills/ Qualifications/ Experience Environmental and Safety Professional, qualified to Diploma or Graduate level Solid grasp of Safety Management Systems Strong working knowledge of occupational health issues Good environmental background an advantage Demonstrable track record of successfully delivering a change in safety culture. Practical working knowledge of food industry occupational hygiene requirements To Apply Please contact Alison Fisher at Hudson Shribman Scientific Recruitment, quoting reference AF/015137. Please call on 020 7421 5200, or reply via email, entering the job title and reference code in the subject field to alison.fisher@hs-scientific.co.uk For up to date career opportunities please visit www.hs-scientific.co.uk Due to a high volume of applicants only shortlisted candidates will be contacted. If you are not contacted within seven days of submitting your CV please assume that your application will not be taken further. If you wish to receive feedback to obtain why your application was unsuccessful please use the contact details provided on the advert. http://www.newscientistjobs.com/jobs/job/team-manager-analytical-chemistry-materials-south-south-east-200639729.htmWed, 18 Nov 2009 09:06:11 +0000190302Team Manager (Analytical Chemistry/ Materials) c£25-30k South Ref: AF/015134 An experienced Team Manager in analytical chemistry (HPLC, LC/MS) with excellent people management skills is urgently required to manage an analytical team who provide a reliable testing service within R&D for a key organisation. As an analytical team manager will be responsible the management for a team who are preparing and analysing test samples using a variety of complex testing instrumentation (HPLC, GC, LC/MS/MS, ICP, GC-MS etc). You will have excellent problem solving skills to develop solutions and provide advice by applying your expertise to solve routine, non routine or novel analytical problems or challenges. Key Responsibilities • Uphold and carry out standard tests undertaken within the Materials Analysis team where there are well established and understood test methodologies. • Support the demands of the laboratory for high volume (all development products will require routine tests) and quick turnaround to produce accurate and timely results for the test requests submitted. • Develop weekly /daily activity (including testing, training, calibration, etc.) plans for team, ensuring that all appropriate options have been considered to meet customer requirements. • Implement talent management strategies to enhance the Team’s skill and flexibility to include: a) performance monitoring; b) multi-skilling; c) ‘specialist’ skills development; and seek opportunities to improve their effectiveness. • Ensure that all daily work routines are conducted in a safe manner, following defined test methods and ISO17025 protocols. Skills/ Qualifications/ Experience - Degree/ MSc/ PhD in Analytical Chemistry/ Materials background - Experience in a variety of complex instrumentation techniques HPLC, LCMSMS, GC, GC-MS, ICP etc - Relevant technical experience resulting in a thorough understanding of supervision in a high volume/quick turnaround ‘routine’ laboratory environment (ISO 17025) - Proven team management / supervisory experience to support and motivate a team in high demand situations. - Ability to understand principles of test processes/methods - Working knowledge of IT applications (Lotus Notes, Word, Excel, etc.) To Apply If you would like to be considered for this role, please contact Alison Fisher at Hudson Shribman Scientific Recruitment, quoting reference AF/015134, outlining your particular skills and experience and their relevance to this post. Please call on 020 7421 5200, or reply via email, entering the job title and reference code in the subject field to alison.fisher@hs-scientific.co.uk For up to date career opportunities please visit www.hs-scientific.co.uk Due to a high volume of applicants only shortlisted candidates will be contacted. If you are not contacted within seven days of submitting your CV please assume that your application will not be taken further. If you wish to receive feedback to obtain why your application was unsuccessful please use the contact details provided on the advert. http://www.newscientistjobs.com/jobs/job/sr-qa-specialist-biopharma-republic-of-ireland-200642064.htmTue, 17 Nov 2009 15:53:13 +0000195409Sr. QA Specialist - BiopharmA This company is one of the world’s leading biopharmaceutical companies. Through acquisitions and mergers, this company has expanded rapidly in its short history and as a result of this continued growth; a new opportunity within this organisation has arisen for a QA Project Manager. This position is responsible for monitoring and supporting the quality performance of contract manufacturers, distributors, material suppliers to all applicable standards for GMP and GDP. This position is responsible for leading, monitoring and supporting the quality performance of European quality systems according GMP & GDP standards. The individual may be responsible for, but is not limited to: • Reviewing and approving batch documentation, data, COAs and supporting QP functions • Supporting batch disposition • Designing and implementing European quality systems and maintaining quality metrics • Approving and leading deviations, change controls, CAPA, investigations and nonconformance reviews, etc. • Leading drug product complaints and support any recall efforts in conjunction with QP • Conducting external audits independently as lead auditor • Conducting training, including GMP/ GDP, for European staff • Implement Technical Quality Agreements, as required • Support Product Quality Review, as necessary • Participating in technology transfer, process scale-up, and process improvement projects. • Leading meetings with external parties and representing the company in a professional manner Essential: • Bachelor’s degree in chemistry, biology or a related discipline • 5 years plus experience working in Quality Assurance, and/or Qualified Person role to support the manufacturing of drugs, biologics, or devices. • Thorough understanding of quality systems and cGMPs. • Experience conducting audits as lead auditor • Interpersonal skills and professional skills to interact with contractors while representing Shire. • Must be flexible and comfortable in a “start up” environment • Must be able to prioritize and multitask in a stressful environment. • Must be able to travel up to 50% (domestic and international) Desired: • Quality experience in parenteral biotech manufacturing (aseptic or sterile processing) • Experience working with a Qualified Person or Responsible Person • Experience interfacing with regulatory bodies or working on regulatory submissions. ************************************************************** TO APPLY DIRECTLY PLEASE CLICK HERE If you would like further information before applying please contact: Brian Christensen BA(Mod.)MedChem on +353 1 685 47 47 http://www.newscientistjobs.com/jobs/job/qa-project-manager-biopharma-republic-of-ireland-200642040.htmTue, 17 Nov 2009 15:43:27 +0000195411QA Project Manager This company is one of the worlds leading biopharmaceutical companies. Through acquistions and mergers, this company has expanded rapidly in its short history and as a result of this conitued growth, a new opportunity within this organisation has arisen for a QA Project Manager. This position is responsible for monitoring and supporting the quality performance of contract manufacturers, distributors, material suppliers to all applicable standards for GMP and GDP. The individual may be responsible for, but is not limited to: Managing priorities and tasks at Contract Manufacturer. Leading and monitoring the daily operations at the Contract Manufacturer. Leading and performing batch review and QA disposition. Designing, Implementing and improving quality systems and metrics. Reviewing and approving; batch records, specifications, deviations, change controls. Leading investigations. Facilitating technology transfer, process scale-up and process improvement projects. Leading meetings of suppliers. Building authentic relationships with Contract Manufacturing. Leading audits. Maintenance of all relevant Technical Quality Agreements (TQAs). Leading Product Complaints and Recall. Leading and assisting in regulatory agency inspections. Supporting the Product Quality Review. Leading training Minimum Bachelor’s degree in pharmacy, chemistry, biology or a related discipline. Extensive experience working in a QA role. Significant experience working in biopharmaceutical industry. Thorough understanding of quality systems, cGMPs, GDPs. Experience with Aseptic/ Sterile Processing. Excellent interpersonal skills and professional skills to interact with contractors while representing the company. Must be flexible and comfortable with ambiguity in a “start up” environment. Must be able to prioritize and multitask in an environment with changing priorities. Must be able to travel up to 50 %. ************************************************************** If you would like further information before applying please contact: Brian Christensen BA(Mod.)MedChem on +353 1 685 47 47 Your details will not be passed to a Third Party without your express Prior Consent. http://www.newscientistjobs.com/jobs/job/senior-qc-analyst-pharmaceuticals-suffolk-up-to-30k-haverhill-200636824.htmWed, 11 Nov 2009 16:26:51 +0000179030Senior QC Analyst - Pharmaceuticals - Haverhill, Suffolk - up to £31k A leading and rapidly growing pharmaceutical company based in the Cambridgeshire / Suffolk area is looking to appoint a Senior QC Analyst to perform the activities required to introduce new products, procedures and processes into the department. Reporting to the Analytical Specialist your key responsibilities will include: - Responsible for the day-to-day running of one of more projects in line with agreed project plans - Participating in authoring the documentation necessary to conduct the various studies undertaken by the group - eg method transfer and method validation studies - Performing the chemical analysis required in accordance with the appropriate protocol - Designing and delivering training on analytical techniques/methods and providing technical support to less experienced colleagues - Critically evaluating current analytical procedures and where appropriate conducting the work necessary to implement improvements - Leading investigations and identifying root causes and appropriate preventative actions To be considered for this opportunity the following skills and experience are essential: - Significant experience in an analytical function - Proven, sustained competence in techniques and skills relevant to the group - Demonstrated ability to work consistently to Quality policies and cGMP - Good communication skills - Degree educated in a relevant scientific subject. Salary will be in line with experience £22 - £31k + excellent benefits package that includes a final salary pension scheme. http://www.newscientistjobs.com/jobs/job/qa-officer-greater-manchester-200634658.htmMon, 09 Nov 2009 18:16:51 +0000175450Quality Assurance Officer- Medical Device/ Quality Assurance Administrator- Medical Device Quality Systems, Documentation, Administration experience in ISO9001 from Pharmaceuticals or Medical Device Sector is Essential. The Package: Excellent Salaries Circa 20-25K + Superb Management + Comprehensive Benefits Package + Superb, Modern Working Environment + Very Good Prospects for further Progression + Immediate Start Available The Client My client is renowned and well-established medical device and healthcare company and is regulated to ISO9001,13485 Quality Management Systems. The Opportunity An immediate opportunity has arisen for a Quality Assurance Officer to play a key role in-house offering support and taking charge of the company Quality Management Systems and the documentation involved from compliance. The main task will be monitoring, preparing and checking documents, database entries and compliance records. The Candidate Candidates should have a background in Quality Assurance involving documentation and quality systems to IS09001, preferably having worked in Medical Device or a similar regulated industry. Awareness of the role of Quality Assurance and ideally familiar with ISO13485: 2003 requirements, the candidate should be familiar with quality documentation. Ideally applicants should hold a higher education qualification in science, preferably biotechnology, chemistry or engineering with good communication and computing skills. The Package + Excellent Salaries Circa 20-25K + Superb Management + Comprehensive Benefits Package + Superb, Modern Working Environment + Very Good Prospects for further Progression + Immediate Start Available The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency. SRG winners of the 2008 Recruiter Awards for Excellence: Best Candidate Care and Best Health Care/Medical Recruitment Firm. http://www.newscientistjobs.com/jobs/job/quality-control-manager-south-east-pharmaceuticals-south-east-200634504.htmMon, 09 Nov 2009 16:16:09 +0000175308If you are a seasoned QC Manager then this is an opportunity for you in a fast growing pharmaceutical product development group. This US based organisation is expanding overseas and is ready to make an impact on the UK market. This senior role will involve maintaining regulatory compliance of all programs in accordance with governmental and European guidelines. You will have at least a bachelors degree within the chemistry or biochemistry subject areas and have significant regulatory QC experience in a multinational pharmaceutical organisation. A GMP qualification is essential. This opportunity will offer you a competitive salary including benefits. To discuss this opportunity please call Scott Peacock on 01279 657716. http://www.newscientistjobs.com/jobs/job/quality-associate-qp-hull-200634000.htmMon, 09 Nov 2009 06:02:33 +0000174718A new exciting position has opened for a Quality Associate, QP, within a leading FMCG company in the East Yorkshire area. This position sits within the R&D side of the business and focuses on ensuring the compliance of suppliers and contractors who provide materials, products and services for the development of new and existing products. Responsibilities of the role include; - approval or rejection of new suppliers and contractors by ensuring activities are fully compliant with regulatory and company guidelines - assessment of suppliers and contractors by questionnaire and site visits - covering starting materials, contract manufactured products, contract laboratories and contract research organisations - creation and maintenance of technical agreements, contractor and supplier lists and re-auditing schedule - development and maintenance of leading edge quality management systems - contribute to the R&D quality systems and provide quality input into development projects This role will involve travel to suppliers and contractors around the UK in order to carry out external audits or site visits. There will also be some travel to EU countries. The successful candidate will have a BSc or equivalent in a scientific discipline with previous experience within the Healthcare/FMCG environment. Broad experience of auditing, and knowledge of regulatory requirements. Strong background and knowledge of the activities of R&D, marketing and supply, and implementing and administering quality management systems are essential. You must be either a qualified QP or be less than 6 months away from qualifying in order to apply for this position. You will have strong communication skills, both written and oral. You will have proven ability to work under pressure and be capable of building strong working relationships. For further information please contact Laura on 0113 391 1200 or apply online. The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency. SRG winners of the 2008 Recruiter Awards for Excellence: Best Candidate Care and Best Health Care/Medical Recruitment Firm. http://www.newscientistjobs.com/jobs/job/despatch-manager-horsham-200632013.htmThu, 05 Nov 2009 12:40:05 +0000169754Summary An excellent opportunity to take responsibility for all aspects of product dispatch as an essential part of the global services in the supply of pharmaceutical products that are utilised in clinical trials. This involves managing a large structured team who undertake an accuracy critical pick and pack process. The Company The company is a global leader in the provision of packaging and logistics services to major pharmaceutical companies who are running trials on a global basis. They operate state-of-the-art facilities that cater for temperature controlled and ambient products in a fully GMP compliant environment. The Role The role carries responsibility for the provisions of picking, packing and despatch capacity and capability to meet client and project needs in the most cost effective manner. This involves the management and development of the teams with three directly reporting shift managers of a three shift system with a total of 35 “Pick and Pack” operators. Promoting a “right first time” focus, key areas include the scheduling of workloads, accounting for operating costs and overall operation profitability and delivery measured against KPIs. In this role you will also ensure HSE compliance, cGMP quality standards, constantly review processes and efficiency plus interface with clients and many of the key departments in the organisation as part of overall clinical supply projects. Benefits In addition to a competitive salary this position has a substantial benefits package that includes annual bonus, non-contributory pension and private health cover. Please note you will need your own transport for this position which is situated just outside of Horsham, West Sussex. Experience You will have proven experience in dispatch management and/or order processing management in a pharmaceutical (or similarly regulated) GMP warehouse environment. Due to the nature of the work the client is looking for evidence of two prime areas of experience. Firstly applicants will need to be a strong person manager who has run a similarly structured and sized despatch team. Secondly your experience will need to include a strong focus on the management of an accuracy and time critical manual picking and packaging operation. Please can you ensure your CV or covering email highlights these particular areas. Keywords: Despatch Manager, Dispatch Manager, Warehouse Manager, Order Processing Manager, cGMP, GMP, Pharmaceutical, Supply Chain Manager, Shipment Manager, Picking & Packing, Pick and pack Manager SLS Services Ltd operates & advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions. http://www.newscientistjobs.com/jobs/job/senior-qc-analyst-pharmaceutical-chemistry-east-anglia-south-east-200631834.htmThu, 05 Nov 2009 11:05:36 +0000169457Senior QC Analyst (Pharmaceutical/Chemistry) c£28-30k East Anglia Ref: AF/015107 An exciting opportunity has arisen for an experienced Senior QC Analytical Chemist with supervisory experience and a good working knowledge of GLP/GMP, gained from working in a pharmaceutical environment, to join an, established Pharmaceutical company. Key Responsibilities The successful QC pharmaceutical chemist will be responsible for setting up a new QC facility on site and building, over time, a small team of analysts responsible for conducting routine analysis of raw materials and bulk products in accordance with current Pharmacopoeial standards. There is the potential for further progression within this role as the facility develops to incorporate finished product testing. Skills/ Qualifications/ Experience Degree in Chemistry, or appropriate scientific discipline. Commercial Pharmaceutical background Knowledge of GLP/GMP Must have commercial practical experience of analytical techniques including wet chemistry, GC, HPLC and a good understanding of the requirements of technology transfer. Good communication skills and computer literacy are essential. Benefits include: 25 days annual leave Annual discretionary bonus Company pension scheme Private Health Care Scheme Post to start Jan 2010 To Apply If you would like to be considered for this role, please contact Alison Fisher at Hudson Shribman Scientific Recruitment, quoting reference AF/015107, outlining your particular skills and experience and their relevance to this post. Please call on 020 7421 5200, or reply via email, entering the job title and reference code in the subject field to alison.fisher@hs-scientific.co.uk For up to date career opportunities please visit www.hs-scientific.co.uk Due to a high volume of applicants only shortlisted candidates will be contacted. If you are not contacted within seven days of submitting your CV please assume that your application will not be taken further. If you wish to receive feedback to obtain why your application was unsuccessful please use the contact details provided on the advert. http://www.newscientistjobs.com/jobs/job/analytical-chemist-qc-essex-200629484.htmTue, 03 Nov 2009 17:07:24 +0000170105NES UK are recruiting for Pharmaceutical Analyst for the contract manufacturing division our pharmaceutical manufacturing client, based at there site in Essex. You will be involved in the analysis of raw materials, bulk and finished products including liquids, syrups, powders and creams. You will need to have experience of using various analytical techniques including HPLC, GC and also have experience of method development. You will also need to be used to working in a very busy QC laboratory and to tight timescales as well as being very accurate in your results. You will need to have a science qualification and also experience working in a busy QC laboratory within pharmaceutical. Experience of the commercial use of HPLC, GC etc is essential as is GLP/GMP. If you feel this is the right role for you please email you CV to geoff.flavell-matts@nes.co.uk http://www.newscientistjobs.com/jobs/job/bioburden-validation-project-manager-london-200629146.htmTue, 03 Nov 2009 15:27:35 +0000166067An individual with extensive microbiological expertise is required to manage and carry out a bioburden evaluation and control project in a biopharmaceutical manufacturing facility. The right person needs to have some years track history in GMP and in pharmaceutical aseptic processes, ideally using a risk-based approach and with experience of the requirements of the FDA. Experience in setting up and managing a bioburden control programme in the pharmaceutical industry is essential. The person appointed will be required to undertake a holistic review of the impact of bioburden on the process as a whole and to devise and execute validation plans, methodologies and protocols for demonstrating control at various stages of the process from raw materials through increasing levels of stringency to the final sterile product. These steps will include fermentation and downstream processing, extraction and purification, formulation, sterilisation by filtration and aseptic filling into final containers. Experience in all these areas of bioprocessing would be an advantage, especially in the more critical stages. The project is part of a wider project to validate a therapeutic enzyme manufacturing process prior to licensure in the US and is linked tightly to the current manufacturing schedule, which also includes programmes of process and cleaning validation. An early start date as soon as can be arranged is required. This is a 6 month contract position. Candidates MUST have hands on experience of biopharmaceutical process. http://www.newscientistjobs.com/jobs/job/laboratory-manager-gfm54805-nottinghamshire-200627377.htmMon, 02 Nov 2009 10:53:19 +0000170102NES Scientific are recruiting for a Laboratory Manager for our client who is an independent contract testing laboratory based in the East Midlands. The role will be running a busy laboratory against tight deadlines and high standards. You will be a Degree qualified or equivalent in a science related subject and have in depth knowledge and experience of laboratory techniques and methods supporting the manufacture of pharmaceutical products, as well as extensive experience of QC operations within a GMP environment. This will include a proportion of your experience spent in a management position. Please apply to Geoff Flavell-Matts at NES now. http://www.newscientistjobs.com/jobs/job/assistant-quality-assurance-manager-birmingham-200623102.htmWed, 28 Oct 2009 13:59:16 +0000157873At Claire’s we believe in quality and quantity. With over 3,000 stores globally, (450 in the UK and Ireland alone) and a huge, sparkling product range of toys, accessories, jewellery and cosmetics, sourced from all over the world there’s a lot to think about when it comes to making sure our exemplary standards are maintained. Luckily, we’ve got one of the best teams in the business, and you could be part of it. Working closely with our buyers at our head office in Birmingham, and suppliers nationwide you’ll examine every product with methodical, hawk-like attention to detail, backed-up by a clear understanding of compliance requirements.’ Test, test and test again’ will be your mantra and clear, accurate labelling your mission. Assisting the more senior members of the team, you could be doing anything from responding to supplier emails from the Far East, to arranging sampling plans and providing legal advice. In short, you’ll ensure that when it comes to standards and the law, every ‘i’ is dotted and every ‘t’ is crossed. Degree educated in Chemistry, you could either come from an analytical, testing background or possibly have spent some time in a trading standards capacity. IT literacy (Excel, Word) and a working knowledge of the ins and outs of the law is essential (although specific legal qualifications aren’t necessary), as is a willingness to travel overseas when required. However, the most important thing, is that you have the Claire’s get-up-and-go, combined with enthusiasm, confidence and a sense of pride in a job well done. To work with like-minded individuals in a fresh and thriving environment, send us your details for consideration and we'll show you how it feels to love your job. http://www.newscientistjobs.com/jobs/job/manager-manufacturing-investigation-report-mircompliance-ny-new-york-200618868.htmThu, 22 Oct 2009 16:06:42 +0000148210Responsibilities: • Manages compliance related activities for the Investigations Personnel assigned to the operational department. Assigns and tracks progress of work against assigned due dates, mentors and trains personnel and provides feedback on performance per Performance Management process or as required. Coordinates with the training manager to assure that training curriculum for staff is current and that training is conducted timely and effectively. Participates in the interviewing and hiring of personnel responsible for the Investigation process. Verifies that these individuals have the required training identified in their curriculum and that performance objectives are written to reflect their responsibilities and are aligned with site objectives. o The primary activities for three Quality Systems managed by the Manager, MIR/Compliance in Pearl River Biotech department are the following: o Manufacturing Investigation Processes: Manages the investigations within their assigned department in Pearl River Biotech. Assures that investigations and commitments from investigations are completed in compliance with procedures and cGMPs. Through monitoring, coaching, training, and collaboration, ensures that investigations and commitments contain accurate technical information and are completed by the assigned due dates. Verifies that an adequate investigative approach is followed to reach the root cause for the deviation. Investigates and reviews investigations. When necessary, elevates investigations concerns to his/her supervisor. o Commitment Processes: Manages the commitments within their assigned department Pearl River Biotech. Assures that commitments from MIRs are completed in compliance with procedures and cGMPs. Through monitoring, coaching, training, and collaboration, makes sure that commitments contain accurate technical information and are completed by the assigned due dates. May investigate and review investigations. When necessary, elevates investigations concerns to his/her supervisor. o Develops and maintains systems for coordinating, tracking, and follow-up on all activities related to Investigations and Commitments. Communicates timely feedback to PPU Management regarding any situation that may result in a compliance issue. Develops metrics and creates reports that communicate overall compliance of the investigation progress in the PPU. • Manager will participate as required as a contact person during inspections and audits. The Manager, MIR/Compliance may escort the inspector/auditors during the inspection process as required. Qualifications: - Bachelor's degree, preferably in a technical/scientific discipline, is required. An advanced degree is a plus - Training in QA, QC, manufacturing processes, camp's, and relevant site Sop's Research and industry experience in products produced at site, experience in dealing with Regulatory compliance. 5-7 years previous pharmaceutical industry experience. 3-5 years of supervisory experience. Experience in problem solving, negotiations, presentation and supervision of a multi-layered organization. Experience in 3 or 4 of the following: Manufacturing Documentation Quality Systems (Manufacturing Investigations), QA/QC/Regulatory, Aseptic Processing, Technical Writing and Compliance. Throughout our 153 years, a legacy of caring for others has been at the heart of everything we do at Pfizer. This commitment is no less important when it comes to our employees. Pfizer wants to ensure that employees have resources to help them develop and succeed both in their careers and personal lives. One way we can achieve this is through our comprehensive benefits program, which offers employees and their eligible dependents the variety and flexibility to help address their needs at different stages in life. Manager, MIR/Compliance for Pearl River Biotech is responsible for performing the functions associated with managing compliance quality systems such as the Manufacturing Investigations process, Corrective Action Process through commitments and Corrective Action/Preventive Action (CAPA). This position provides leadership to ensure timely closure of investigations and commitments resulting from investigations. This position directly supervises a group of Investigators. This position assures effective and efficient cross-functional team meetings. Establishment of performance goals and strict adherence to cGMP's is required. HOW TO APPLY: Please copy and paste the following URL into your browser address bar: http://posttrak.arbita.net/cgi-bin/PostTrak.cgi?RefCode=R9250125807847 http://www.newscientistjobs.com/jobs/job/bioanalytical-development-scientist-biochemist-hplc-elisa-pharma-united-kingdom-200610936.htmTue, 20 Oct 2009 08:57:54 +0000146388Bioanalytical Development Scientist (Biochemist HPLC/ ELISA) c£25-30k South Ref: AF/015026 A fantastic opportunity for a bioanalytical development scientist (HPLC/ ELISA) to support the Process Development Department has arisen for a pharmaceutical organisation. The scientist will work in an expanding team, established to support the manufacture of medicines. The analytical methods used include SDS-PAGE, iso-electric focusing, HPLC methods, ELISAs and spectroscopic techniques; as well as other methods employed in pharmaceutical analysis, such as Karl Fischer and particle counting. The analytical capabilities of the team are expected to expand further. Job Responsibilities • To analyse samples, using appropriate methods, to the required standards, producing high quality data. To develop and validate analytical methods, as appropriate. • To ensure that equipment/instrumentation is calibrated and maintained and that laboratory records/documentation comply with GMPs. • Performs job responsibilities in compliance with cGMPs and all other regulatory agency requirements. • To be a member of project teams and to ensure the completion of tasks within agreed timeframes. • Presenting results in oral or written reports to the relevant supervisor and to produce technical documentation packages on projects under the guidance of the supervisor. • To work in compliance with company and regulatory requirements, and to ensure that client-confidential information is protected at all times. Qualifications, Skills and Experience: Life Sciences Background (Biochemistry/ Bioanalytical) Method validation and development using protein structure/function characterization techniques such as: SDS-PAGE, Iso-electric focusing, HPLC methods, ELISA’s, FTIR, Differential Scanning Calorimeter (DSC), Western Blot, Spectroscopic techniques and pharmaceutical techniques such as Karl Fischer and particle counting. To Apply If you would like to be considered for this role, please contact Alison Fisher at Hudson Shribman Scientific Recruitment, quoting reference AF/014824, outlining your particular skills and experience and their relevance to this post. Please call on 020 7421 5200, or reply via email, entering the job title and reference code in the subject field to alison.fisher@hs-scientific.co.uk For up to date career opportunities please visit www.hs-scientific.co.uk Due to a high volume of applicants only shortlisted candidates will be contacted. If you are not contacted within seven days of submitting your CV please assume that your application will not be taken further. If you wish to receive feedback to obtain why your application was unsuccessful please use the contact details provided on the advert.