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- Responsible for leading validation, qualification and verification of manufacturing equipment, facilities and laboratory systems.
- Author, execute and report validation activities within the framework of GMP - Annex 11 & 15 and in compliance with the QMS requirements.
- Work with external companies to ensure activities thatrequire specialist knowledge are completed in a compliant manner.
- Experience leading qualification/validation activities within the biopharmaceutical, ATMP or related sectors (e.g. cleanrooms, lab equipment, monitoring systems).
- Demonstrable experience of validating manufacturing/laboratory equipment, facilities and processes including the generation/execution of lifecycle documents in a biopharmaceutical or related industry tothe required quality and regulatory standards (Annex 15 and 11).
- Experience of successful interfacing with multi-functional project teams and external contracted resources to develop requirements, establish programs and complete the validation.- A knowledge and understanding of how to implement the GAMP guidance.
Senior Validation Specialist - Cambridge, United Kingdom - CK Science
Description
Senior Validation Specialist
CK Group are recruiting for a Validation Specialist to join a growing Cell Therapy CDMO to be based at their site in Cambridge on a permanent basis.
Job Summary:
You will have the following experience/qualifications:
To