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Team Leader (Supervisor) Quality Assurance Executive - South - Pharmaceutical

Team Leader (Supervisor) - Quality Assurance (QA) Executive c25-28k
South Ref: AF/015207

A Quality Assurance (QA) who is looking to undertake a supervisory role for a small team is urgently required for a key pharmaceutical company. You will be a senior member of a team within the Quality Assurance (QA) Group that exercises quality oversight and reviews documents and data generated by the analytical chemistry development teams.

• Review of PDS documentation for accuracy and compliance with cGMP. This will include but is not limited to review of; batch manufacturing records (BMRs), project documents, calibration protocols, validation protocols and standard operating procedures.
• Review of analytical data to ensure accuracy, traceability, integrity and that it has been generated and recorded in compliance with cGMP and local SOPs. This will include but is not limited to a review of: laboratory notebooks, supplementary files, analytical requests, interim stability reports (ISRs), certificates of analysis, reports and data in Empower. Check for errors and anomalies and assist in the resolution of associated issues.
• Verify that the experimentation has been performed in accordance with the appropriate procedure and or testing protocol. Identify anomalies and report them to the analyst’s team leader or section manager.
• Perform internal audits against current GMP standards and ISO9001 as the schedule dictates and maintain site inspection ready status.
• Ensure cGMP standards are applied in their area of work and ensure that cGMP standards are complied within all areas of the business.
• To perform reviews of analytical data and documentation in the laboratory in preparation for audits.
• To work in compliance with Company and Regulatory requirements; and to ensure that proprietary information is protected at all times.
• Give QA oversight to activities within PDS.
• Maintain knowledge of site policies and procedures, especially the quality system.
Ideal candidates will have:
• A minimum of HND/HNC or BSc in a Scientific subject
• Previous Quality Assurance QA / auditing experience
• GMP experience, preferably within a laboratory environment
• Supervisory / team leadership experience
• A good working knowledge of a wide range of analytical techniques.
• An understanding of/exposure to regulatory guidelines.

To Apply Please contact Alison Fisher at Hudson Shribman Scientific Recruitment, quoting reference AF/015207, 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.