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CK Group are recruiting for a Validation Manager on behalf of a growing Cell Therapy CDMO to be based at their site in Cambridge, on a permanent basis.
The Role:
Reporting to the Head of Quality, you will be responsible for leading the Validation function by building the team and developing its capabilities. This will include ensuring activities associated with manufacturing and lab equipment, facilities, utilities, laboratory, and computer systems are completed, in accordance with GMP requirements.
Responsibilities
: Manage a team and ensure validation master plans (VMPs), protocols and procedures are established. To prepare and maintain validation plans (VPs) and identifying validation requirements. Assist in the authoring of User Requirement Specifications, DQ/IQ/OQ/PQ protocols, and reports for validation purposes. Working with external companies and project teams to ensure activities that require specialist knowledge are completed. Executing validation protocols for equipment, facilities and utilities Your Background: Degree (or equivalent) in a Science or related discipline. Qualifications related to validation and quality compliance (GMP/ ICH/ FDA/ USP/ EP policies). Experience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation of lifecycle documents (URS, DQ, IQ, OQ & PQ) in a biopharmaceutical. Significant experience leading validation activities within the biopharmaceutical or ATMP sectors. Understanding and experience of aseptic processing and cleanroom technologies. Proven track record of establishing validation master plans (VMPs).
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: Manage a team and ensure validation master plans (VMPs), protocols and procedures are established. To prepare and maintain validation plans (VPs) and identifying validation requirements. Assist in the authoring of User Requirement Specifications, DQ/IQ/OQ/PQ protocols, and reports for validation purposes. Working with external companies and project teams to ensure activities that require specialist knowledge are completed. Executing validation protocols for equipment, facilities and utilities Your Background: Degree (or equivalent) in a Science or related discipline. Qualifications related to validation and quality compliance (GMP/ ICH/ FDA/ USP/ EP policies). Experience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation of lifecycle documents (URS, DQ, IQ, OQ & PQ) in a biopharmaceutical. Significant experience leading validation activities within the biopharmaceutical or ATMP sectors. Understanding and experience of aseptic processing and cleanroom technologies. Proven track record of establishing validation master plans (VMPs).
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