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CQV Documentation Engineer

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Life Sciences
37622
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CQV Documentation Engineer - US, North Carolina

Our client, a global pharmaceutical manufacturing organisation are looking for a talented X to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Responsibilities:
  • Ability to read and understand CQV and site quality procedures and align with FDB Large Scale Biologics operating principles and regulatory requirements.
  • You will have the responsibility for closing out CQV teams, IV/ OV protocols along with working closely with QA to close out IQ/OQ summaries
  • Ability to work with an electronic validation system such as KNEAT or similar systems.
  • Conduct GDP reviews of test protocols pre and post execution to facilitate a timely review and approval process with Quality.
  • Utilize and own GDP checklist to track errors found in protocols and other documents. Update checklist as needed to ensure comprehensive list of potential GDP errors.
  • Conduct general documentation reviews of specifications, design documents, procedures, work instructions, etc. to ensure GDP requirements are met and standard formatting is maintained.
  • Liaise with CQV Leads, CQV Engineers and other departments to resolve GDP errors in protocols and documents.
  • Drive timely protocol closure for each phase of CQV.
  • Track and report weekly protocol closures.
  • Train CQV teams on GDP standards.
Requirements:
  • Requires extensive experience in a similar documentation review and/or Quality Assurance role for cGMP Documentation.
  • Prior experience with cGMP or in other highly regulated industries such as on Large Scale Projects and/or GMP operational facility.
  • Experience with liaising with other departments and engineers/QA, ensuring streamlined implementation of documentation review process or similar type process.
  • Willingness to step in a proactive manner for driving progress
  • Strong communication skills and ability to escalate issues as needed.
  • BA/BS in a related field and strong experience successfully executing complex projects in a Pharma/cGMP environment.
  • Emphasis for this hire is on attitude (Positive Can-Do attitude) and strong collaboration.
  • Acts with detail-driven ownership and follow through.

If you are interested, please apply now for immediate consideration and further information.

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