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Validation Manager
4 months ago
Blackfield Associates are partnered with a CDMO client based in the Cambridge area looking for a Validation Manager on a permanent basis.
The Validation Manager will be leading the validation function to be able to execute report activities within the framework of GMP - Annex 11 & 15 in compliance with QMS requirements. In addition, they will be supporting multiple validation projects, liaising with the project departments and the associated departments to ensure work is completed in a timely manner.
Other responsibilities include:
- Ensuring Validation Master Plans (VMPs), protocols, and procedures are established to facilitate the delivery of validation activities to the require regulatory standards.
- Oversee User Requirement Specifications, DQ/IQ/OQ/PQ protocols, and reports for validation purposes.
- Supervise validation testing performed by vendors to ensure work is accurate, critically review results and work with vendors to report deviations.
- Manage requalification of systems and equipment in accordance with procedures to maintain validated states.
- Support implementation of a risk-based approach to the validation of systems to ensure compliance with Annex 11 and 15.
This is an excellent opportunity for anyone wanting to be involved with Advanced Therapy Medicinal Products (ATMP) manufacturing.
