Quality Validation engineer
Real Life Sciences
2 dagen geleden
source : Experteer

Real Staffing is a Recruitment & Consultancy Company specialised in the Life Sciences Industry. Our office in Brussels works closely with players in the Pharma, Biotech & Medical devices sectors.

We are currently helping one of our clients to find a Quality Validation Engineer to help our client to grow.Our Client is a key actor in the Life Sciences IndustryAct as a validation representative for WFI project that include computerized system validation and qualification activities : * Define the validation methodology and approach for the project.

  • Provide validation expertise and quality assurance guidance for the development of the project : direct involvement in the definition of the process / system specifications.
  • Participate in the risk assessment related to the project.* Review URS, FS and DS for validation requirements and all applicable QA requirements.
  • Participate in the determination of process or system controls.* Participate as part of the project team in the definition of the user requirements and functional specifications of automated processes* Prepare validation documentation in compliance with Baxter and cGMP requirements and assure application of these requirements* Prepare and implement FAT, IQ, OQ & PQ Protocols.

  • Assure traceability throughout the whole project validation file (from URS to PQ).* Organize and coordinate FAT, IQ, OQ, PQ activities with the different involved departments and in such a way that all of them concur to the timeframes committed with the project leader.
  • Analyze, interpret, document and report the testing results.* Collect and approve results of validation activities, assure issuance of reports and allow release of impacted product in accordance to internal procedures* Participate in the writing of specifications and SOP's related to automated manufacturing processes* Ensure the follow-up and tracking of the validation's activities.
  • Update the validation documentation system.You have an experience in a similar position Or have worked on a project connected to CSVFluent in Both French & EnglishAs a key Player within the Life Sciences & the STEM Industry, our team offers you a tailored made approach to help you to drive your career.

    Joining our team will allow you to grow and develop both your your hard skills & soft skills and to get access to our portfolio of clients within the Pharma / Biotech / Med Dev environment.

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