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CQ Documentation Engineer

  1. Germany, Frankfurt
Frankfurt am Main
  1. Contract
Competitive
  1. Life Sciences
38133
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CQ Documentation Engineer - Germany, Frankfurt - 18 Month Contract

We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Frankfurt. Due to a large capital investment and multiple projects on site, the client is looking for a CQ Documentation Engineer  to join their team.

Responsibilities include:
  • Coordinate with Document Preparation Lead on deliverables and approvals using the Document Generation Tracker to manage milestones and timelines.
  • Oversee Verification Design deliverables (EDR/DQ) and review/approve vendor documentation.
  • Manage documentation for Factory Acceptance Testing (FAT).
  • Support protocol development (FAT/IV/SAT/FV) with the Document Preparation Lead.
  • Liaise with vendors to ensure GEP/GDP compliance for test documentation.
  • Contribute to CQV schedule planning and milestone tracking.
  • Lead protocol review/approval in KNEAT and manage IV execution (walkdowns, tag verification, loop checks, STW, PSSR, DSTW).
  • Lead FV execution activities (start-up, debugging, ACO, SAT, phase/recipe testing).
  • Manage the timely closure of all CQV Punchlist items
  • Liaise and utilize Engineering Change Management System (ECM)
  • Review and approval of all Vendor Turnover Packages and Field Turnover Packages against the VDR and to ensure these support the Validation Requirements for the system
Key requirements include:
  • Prepare CSRs (Commissioning Summary Reports) for executed documentation
  • Ensure all the requirements for the IOQ summary reports are available and the good engineering and documentation practices have been followed throughout.
  • Review all vendor and site change controls for impact to the completed testing as required. 
  • Generate Project specific SOP's / other documentation as applicable
  • Support CQV and QA programmes as required
If you are local to Frankfurt and interested in discussing this position, please submit your profile and we will be in contact at our earliest convenience.
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