Senior Quality Assurance Specialist

Vivid Resourcing London
05 Oct 2017
13 Oct 2017
Contract Type
Full Time
Responsibilities: - Foster and promote GMP, GDP and the associated Quality Management Systems within the site - Review Finished Batch Record and GMP Release for final QP Release - Support ongoing preparation for Regulatory and Client audits, ensuring timely audit response and completion of agreed actions on time - Oversee and input to CMO related Change Control, Non-conformance and CAPA activities; ensuring appropriate training of team as required - Integrate with the QEHS group on audit activities ensuring an adequate program executing audits as required. - Enhance and develop Quality Management System activities associated with the release of CMO product, integrating as appropriate into central activities - Ensure appropriate maintenance of filing of CMO related documents - Implement and ensure correct usage of appropriate Database(s) for the support CMO Activities. Qualifications & experience: - Bachelors Degree in Science, Engineering or related discipline - Quality Management experience 3 - 5 years minimum in a pharmaceutical environment - Experience working in a GMP environment - Regulatory experience desirable - A well-organised approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing. - Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.
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