Job Reference: J5633430
Updated On: 01/07/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for a QA Specialist to join a leading biopharmaceutical company based in the Cambridgeshire area. As the QA Specialist you will be responsible for ensuring GMP compliance and the maintenance of the site Quality Management Systems (QMS).
Key Duties and ResponsibilitiesYour duties as the QA Specialist will be varied however the key duties and responsibilities are as follows:
1. As the QA Specialist you will support document review and management, raising and investigating deviations, and change control oversight.
2. As the QA Specialist, you will ensure that all stages of Good Manufacturing Practice (GMP) are in full compliance with guidelines and other regulatory requirements across site and systems. You will maintain processes and SOPs, including GMP document control and training, ensuring the site is always compliant.
3. In your role as the QA Specialist, you will support staff with training and compliance, CAPAs, GMP Documentation, Change Controls and incidents.
4. You will be responsible for the approval of validation documentation and assisting in the maintenance of the quality management systems.
Role RequirementsTo be successful in your application to this exciting opportunity as the QA Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences discipline.
2. Proven industry experience working within GMP guidelines.
3. A working knowledge and practical experience with developing and approving Quality documentation.
Key Words: QA | Quality Assurance | Quality | GMP | Audit | MHRA | Pharma | CAPA | Documentation | QMS | Quality Systems | Senior | R&D | Manufacturing | Good Manufacturing Practice
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