Senior Validation Specialist

☞ CK Group

View: 107

Update day: 11-05-2024

Location: Cambridge East

Category: Pharmaceutical / Chemical / Biotech

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Job content

  • Salary:Competitive
  • REF Number:00056707
  • Consultant:James Horne
  • Contact:0191 370 6483
  • Date Published:08.03.2024
  • Sector:Pharmaceutical, Biotechnology
  • Location:Cambridge, South East
  • Discipline:Quality

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:

  • 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.

You will have the following experience/qualifications:

  • 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.

To Apply:

For more information, or to apply for this Senior Validation Specialist position please contact James Horne on 0191 370 6483 or email jhorne@ckgroup.co.uk. Please quote job reference 56707 in all correspondence.

It is essential that applicants hold entitlement to work in the UK

James Horne

Senior Recruitment Consultant

T: 0191 3848905

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Deadline: 25-06-2024

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