Qualified Person (QP) GMP

Job Description: Qualified Person (QP)

RRxCo has been exclusively retained by an exciting and growing pharmaceutical company to help them find the next QP.

This role is suitable only for candidates who are already qualified as a QP and can be in the Greater London (West) office weekly. The position will be hybrid.

The Qualified Person is responsible for performing release activities and leading batch assessments to ensure timely and compliant product releases, meeting quality and regulatory standards.

Key responsibilities include:

1. Quality control and batch release of pharmaceutical products manufactured and tested by CMO and third-party laboratories.
2. Promoting adherence to Quality Policies, SOPs, and training programs.
3. Ensuring GMP compliance for all marketed products.
4. Conducting internal and external audits and supporting authority inspections.
5. Handling technical customer queries and product investigations.
6. Communicating effectively with internal and external stakeholders.
7. Implementing new legislative and regulatory requirements promptly.
8. Managing relationships with MHRA regarding quality issues, batch recalls, and information requests.
9. Completing QP declarations and managing quality functions related to APIs.
10. Reviewing quality documentation such as batch certification, validation, audit reports, and others.
11. Reviewing CMO batch records and analytical Certificates of Analysis to ensure compliance with EU guidelines.
12. Managing deviations in manufacturing and quality procedures, ensuring proper reporting.
13. Approving manufacturing change controls and ensuring regulatory compliance.
14. Ensuring quality control checks and tests are performed as per procedures.
15. Maintaining a record of certified product batches.
16. Providing regulatory guidance and best practice advice.
17. Reviewing technical agreements and managing recall procedures.
18. Contributing to the improvement and maintenance of the quality management system.
19. Writing, reviewing, updating SOPs, and providing training to staff.

This is an urgent role; please get in touch promptly for full details.

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