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Upstream C&Q Lead

  1. Eastern Europe
Budapest
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
11-07-2023
31544

This vacancy has now expired

Upstream C&Q Lead- Life Science – Contract – Hungary

Our client, One of the world’s largest pharmaceutical organisations 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 Upstream C&Q Lead.
                    
Upstream C&Q Lead Responsibilities:
  • 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.
  • Effectively interact with leadership and partner with C&V Leadership, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define the commissioning & verification requirements for the assigned workstreams. This would include documentation of critical aspects, risk assessments, verification testing strategy, and acceptance criteria.
  • 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 internal Quality Standards, cGMP requirements, and approved verification requirements / strategy related to the assigned work stream.
About you:
  • Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution.
  • Minimum 4 years technical experience.
  • Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.
  • Communication Skills: Excellent oral and written communication skills, including presentations.
  • Ability to write clearly, concisely, and persuasively in a professional environment.
Are you a good fit for a Upstream C&Q Lead? Get in touch with us today.

The candidate must have the rights to work in the location stated in the job advert.

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