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Commissioning & Qualification

  1. Brussels
Brussels
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
15-04-2024
33591
Senior C&Q Single Use Qualification SME - Brussels - 12-18-Month Contract

We are looking for an experienced Commissioning & Qualification for a fantastic 12-18 month contract based in Brussels.

You will be working with our client, a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease. This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.


Responsibilities:

  • Draft CQV documents, coordinate review and approval of applicable single use C&Q documents (QRA/DV/RTM/IOV/VSR) following approved single use VMP.
  • Act as C&Q Subject Matter Expert and Compliance for single use. Ability to provide guidance and work with supplier and all C&Q activities from design to execution and to summary report approval.
  • Deep understanding of single use requirements such as Biocompatibility /Mechanical properties/ USP / E.P.5.2.8. /Extractable/Leachable /Chemical compatibility/ Endotoxin /Sterilization/ Integrity/Particulates/ Packaging/labelling/Storage/ Expiration/ Release.
  • Deep understanding and experience of all types of single use verification and testing requirements in the field such as Pressure test/ Homogeneity/ Extractable/ Leachable/ Stability/ Chemical compatibility / Filling and mixing system (homogeneity)/ Sterilization validation/ Filter Integrity test/ property

Requirements:
  • 5+ years of hands-on, end to end experience with SINGLE USE EQUIPMENT in International CAPEXC&Q
  • Extensive knowledge and demonstrated experience delivering single use verification for Pharmaceutical / Biotechnology projects including automationrelated aspects.
  • Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.
  • Knowledge of safety, GMP and environmental regulatory requirements

If this role is of interest to you, please apply now! 

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