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Senior Auditor, Corporate Compliance

Summary
Senior level Auditor for Corporate Compliance opportunity with a global market leading provider of services to the drug development industry. This group wide role is to head up cooperate compliance operations through structured global audit programmes and clear regulatorary leadership.

Job Description


The Company
Our client leads the market in the provision of pharmaceutical research, development and manufacturing services from their sites across the globe. The company has grown significantly in recent years in order to “engineer a better drug development process through scientific excellence”. Europe sites are situated in both the UK and mainland Europe and the role will be based at the Edinburgh hub with group wide responsibilities.

The Role
We are seeking a Senior Auditor professional in Pharmaceutical Corporate Compliance, to support the execution of global audits using ensuring current regulatory requirements, internal standards, policies and procedures are met. This role will support site regulatory and key client inspections by providing technical expert consultancy in preparing and responding to potential compliance issues. The role holder will participate in site assessment by providing technical expert consultancy and regulatory knowledge to aid creation and support of site remediation activities. This includes providing clear information and input to key metrics when assessing the state of compliance during audits and assessments. In addition the role supports the creation and execution of site compliance remediation plans through providing project management support and the publication of Global standards for key metrics on the Global state of compliance.

Specific responsibilities include the execution of the Global Audit schedule; participating as lead/support auditor during internal and external audits; providing project management support during the creation and execution of site’s compliance remediation plans; providing expert consultancy and support for defined regulatory and key client inspections; developing and maintaining internal audit/inspection methodologies and keeping the company’s knowledge of regulatory requirements and industry standards current.

Experience
To succeed in the role of Senior Auditor, Corporate Compliance you will BS or BA in a relevant discipline with significant years experience in Auditing, Compliance or Quality Assurance at an appropriate senior yet “hands on” technical level. Qualified Person (QP) certification will be advantageous though not essential. Desired areas of experience include commercial product filing, process validation, engineering, facilities, and/or manufacturing, including parenteral products. You will be able to demonstrate customer focused skills with the necessary technical skills to conceptualise, develop, and implement strategic compliance requirements. You will also have a sound knowledge of the drug discovery and development processes and the GxP regulations that apply.

Keywords: Compliance Manager, Auditor, Senior Auditor, Quality Compliance, QA Manager, Quality Assurance Manager, GMP, QP, Qualified Person, cGMP, GCP, GDP GAMP, GLP, Auditing Manager, Corporate Compliance

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