Job Reference: J5633672
Updated On: 24/08/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for a QA Officer to join an ATMP company based in the South East. As the QA Officer, you will be responsible for ensuring site wide, GMP compliance and product quality requirements are met, at all times.
Key Duties and ResponsibilitiesYour duties as the QA Officer will be varied however the key duties and responsibilities are as follows:
1. Provide QA review and approval of batch records, working closely with the site QP, ensuring all documentation is present and the timely and adequate release of GMP compliant products.
2. As the QA Officer, you will provide QA support and oversight to the wider business, to ensure compliance with regulatory requirements from MHRA, EMA and FDA standards. This will include aiding in the management of the site QMS.
3. You will review, amend, create and approve SOP's. You will provide assistance in wider QMS management, including Root Cause Analysis, Risk management, CAPA's, change controls and OOS.
4. Whilst aiding in the management of GMP compliance, you will participate and conduct internal audits. This will include supporting in regulatory agency audits and inspections.
Role RequirementsTo be successful in your application to this exciting opportunity as the QA Officer we are looking to identify the following on your profile and past history:
1. You will have previous experience working within a GMP environment. Although not essential, it would be desirable to have worked within a sterile manufacturing environment.
2. Previously helped manage and develop a pharmaceutical Quality Management System. (QMS)
Key Words: Quality Assurance | QA | Quality Officer | QA Officer | GMP | GXP | ATMP | Cell Therapy | Gene Therapy | Pharma | Bio | Audit | MHRA | FDA | Quality Management | CAPA | Inspection | Batch
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