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CQV Lead

  1. Eastern Europe
  1. Contract
Competitive
26303
  1. Commisions, Qualification and Validation
Date Posted13 Apr 2021
CQV Lead - Contract - Remote

Our client is one of the world’s largest pharmaceutical organisations and is responsible for developing and  manufacturing medicines and vaccines for a wide range of medical disciplines. They have been responsible for the development of many blockbuster drugs in both the USA and the EU and have a presence in the USA, EU and Asia-Pacific.

With continued organisational growth and a considerable amount of investment across the portfolio and capital programme they are seeking the expertise of a CQV Lead to support their CAPEX project in Central Europe.

We are looking for an experienced CQV Lead to join this project for an initial 12-month contract on a multiple year project. This would be a great opportunity to join a project in the early design stages and support it through the full lifecycle. The project scope involves design, construction, and Qualification of a new biopharmaceutical drug substance facility on an existing site.

This would be a remote working position for the initial year with aim to be site based in 2022 during the execution of the project.

Essential Duties and Responsibilities for this CQV Lead role include, but are not limited to, the following:
  • Support the project set-up from the CQV perspective
  • Create and oversee the execution and implementation of the site CQV strategy throughout the full project lifecycle (design through to handover to operations)
  • Serve as the primary Commissioning & Verification (C&V) Subject Matter Expert for Concept Design through to site Qualification - Commissioning and Verification (aka Qualification) will follow the ASTM E2500 principles and standards.
  • Review of technical specification documents, drawings, and vendor design submittals (including FAT, SAT, IQ/OQ), with a specific focus on GMP-critical aspects and impact on commissioning & verification.
  • Review and assess vendor documentation and executed testing (e.g. FAT, SAT) for adherence to GMP and project requirements.
  • Lead and participate in development and execution of complete verification documentation in accordance with Client’s Quality Standards, cGMP requirements, and approved verification requirements / strategy related to the assigned work stream.
  • Collaborate with other work stream leads to ensure effective integrated verification strategy of integrated systems and equipment.
  • Provide or arrange for development of complete verification documentation in accordance with Client’s Quality Standards and cGMP requirements for assigned work stream.
  • Collaborate with matrix organisation to optimise Change Control implementation and management.
  • Maintain a working familiarity with current industry best practices and cGMP requirements. Maintain technical skills in the latest techniques for project management and pharmaceutical processing technology.
  • Assist Project Manager with the preparation of C&V status reports: include descriptions, justifications, cost estimates, budgets, schedules, analysis of alternatives, verification requirements, and other required information.
A successful applicant for the CQV Lead position would have the following skills/experience:
  • Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution
  • CQV Lead experience within large CAPEX Greenfield or Brownfield projects
  • Previous pharmaceutical/bio-pharmaceutical project experience with a solid working knowledge of cGMP and facility/equipment validation requirements
  • Experience supporting full project lifecycle (design to handover)
  • ASTM E2500 experience Risk based verification knowledge and experience
 If this sounds like the position for you then please apply today!




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