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Project QAV Manager

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. CAPEX Projects
02-06-2023
30080

This vacancy has now expired

Project QAV Manager – Pharmaceuticals – 12 Month Contract – Denmark

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Project QAV Manager to join them on their new expansion project. Based in a charming Nordic location, this on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.

As the Project QA Manager, you will be responsible for supporting the delivery of a highly complex large scale drug product facility.

Project QAV Engineer Responsibilities:
  • Lead major processes, supporting equipment such as Automatic Inspection line, Formulation equipment, Sterile Filtration skid, Part Washer and Autoclave.
  • Input to, review and approval of documents related to IT & Automation systems such as Pas-X (EBR/MES), VDS and Delta V is also expected.
  • Actions related to FAT prerequisites e.g., ensure that Change Management Records (CMR) are in execute, perform GDP training of Vendor’s testing personnel etc.
  • Review and approve validation documentation (protocols, design specifications RTM etc.)
  • Participate in Quality Risk Management processes
  • Review test documentation (FAT/SAT/IQ/ OQ/PQ) including deviations found during testing
  • Supervise of vendors/contractors during relevant validation activities to ensure correct level of quality
  • Turnover package reviews, both from vendor and contractor.
About you:
  • Prior QA experience
  • Knowledge of regulatory requirements for aseptic processes and validation (EU GMP Annex 1 and Annex 15)
  • Working knowledge of principles, concepts and practices of ASTM E2500 / Leveraging Verification process
  • CAPA, Deviation and Change Control handling
  • SME on Quality and Compliance issues
  • Experience with projects and working in or around operating facilities
Are you a good fit for this Project QAV Engineer job? Get in touch with us today to apply.

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

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