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QA/Validation Engineer

  1. Home Counties
  1. Permanent
Competitive Rates
  1. Commisions, Qualification and Validation
Date Posted27 Jul 2020
Brilliant Opportunity in central London for a Quality Assurance Specialist to support a rapidly growing Gene Therapy company with their transition into commercial manufacturing.

They are looking for someone to provide QA support for all validation and qualification activities across the Manufacturing facility and Laboratories. To ensure processes, analytical methods and equipment are appropriately validated and qualified in accordance with EU and FDA regulations.

Job Responsibilities
  • Review and approve tech transfer, validation, qualification protocols and reports.
  • Maintain understanding of cGMP, Good engineering practices and guidance in relation to all aspects of validation across manufacturing, analytical laboratories and facilities.
  • Support the generation of Process Validation, Analytical Method Validation and Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality.
  • BSc in Science / Engineering
  • The successful candidate must have experience in GMP manufacture of parenteral products, with an emphasis on aseptic manufacturing.
  • Experience of GMP manufacturing requirements, the validation of facilities, processes, equipment and analytical methods.
If this role would suit your skillset and experience then please apply now!

The candidate must have the rights to work in the location stated in the job advert.

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