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CK Group are recruiting for an experienced Senior Validation Specialist to join a growing Cell Therapy CDMO to be based at their site in Cambridge, on a permanent basis. This role will be fully onsite.
The Role:
Reporting to the Validation Manager, you will support multiple projects, liaising with project teams and other departments to ensure validation status is maintained. You will also be required to deputise for the Validation Manager, as needed.
Responsibilities
: Supporting the implementation of a risk-based approach to the validation of systems to ensure compliance with Annex 11, 15 and industrial guidance such as GAMP 5 guidelines. Preparing validation plans, assisting system owners with impact assessments, risk assessments and identifying validation requirements for equipment, facility and systems projects. Preparing and executing validation protocols for equipment, facilities, utilities, computerised systems, and processes. Managing requalification of systems and equipment. Supervising validation testing performed by vendors. Your Background: Degree (or equivalent) in a Science or related discipline. Experience leading validation activities within the biopharmaceutical ATMP or related sectors (e.g cleanrooms). Knowledge of relevant regulations (GMP/ ICH/ FDA/ USP/ EP policies). Demonstrable experience of generation and execution of validation lifecycle documents(URS, DQ, IQ, OQ & PQ). Understanding and experience of aseptic processing and cleanroom technologies.
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: Supporting the implementation of a risk-based approach to the validation of systems to ensure compliance with Annex 11, 15 and industrial guidance such as GAMP 5 guidelines. Preparing validation plans, assisting system owners with impact assessments, risk assessments and identifying validation requirements for equipment, facility and systems projects. Preparing and executing validation protocols for equipment, facilities, utilities, computerised systems, and processes. Managing requalification of systems and equipment. Supervising validation testing performed by vendors. Your Background: Degree (or equivalent) in a Science or related discipline. Experience leading validation activities within the biopharmaceutical ATMP or related sectors (e.g cleanrooms). Knowledge of relevant regulations (GMP/ ICH/ FDA/ USP/ EP policies). Demonstrable experience of generation and execution of validation lifecycle documents(URS, DQ, IQ, OQ & PQ). Understanding and experience of aseptic processing and cleanroom technologies.
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