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CQV Resource Support

  1. Belgium, Brussels
Brussels
  1. Contract
Competitive
  1. Life Sciences
38192
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CQV Resource Support - Belgium, Brussels - 5 Months Initial Contract

We are looking for an experienced CQV Resource Support for a fantastic 5 month contract based in Brussels.

You will be working with our client who are 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:
  • Review executed tests to ensure that the executed Test and the Pre-defined test within the test document (Protocol) are aligned and the executed test meets GDP standards
  • Verify the supporting test documentation attached to the test are complete and meet the test expectations
  • Progress open defects (non-conformances) and close out ensuring Quality are aligned
  • Progress Technical Change Control (TCR’s) from “pre-execution” approval stage to “post execution” approval stage by locating and if required completing the required verification tests documented pre-defined in the TCR.
  • Follow up with Vendor any outstanding documentation required to support verification tests eg material certificates, user manual, pump curves etc
  • Draft Validation summary reports and follow up with the applicable support teams for support documentation eg DIRA, Maintenance Plans etc
  • Ongoing alignment with Quality, keeping Quality up to date with technical conclusion and rationales
  • Move approved interim VSR’s to approved VSR’s by removing outstanding blocking points on the interim VSR’s
  • Role will involve driving activities forward and to completion
  • Proposing solutions to overcome challenges
Requirements:
  • Requires extensive experience (mid to Senior profile)
  • Technical understanding of Process Equipment (Autoclaves, Filling Lines and Manual Cleaning) from a mechanical and automation standpoint
  • Experience with finalising reports for Deviations, Non-Conformances, Change controls etc
  • Experience with reviewing and approving URS, FAT/SAT, DIRA’s, IOV/IQOV documentation essential
  • Complete reports, templates, risk assessments, maintenance plans
  • Review and close outstanding change controls
  • Someone who is proactive and will drive this portion of the project forwards
  • Strong communicator who can liaise with key stakeholders and Management
If this role is of interest to you, please apply now!
#LI-CB1



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