Validation Engineer Role Cork

QA Validation Associate

  • Posted Dec 13, 2022
  • Cork
  • Contract
  • BBBH26042

LSC have a great contract opportunity for QA Validation Associate to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's.
  • Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
  • Lead and represent Validation in multi-departmental meetings & project teams.
  • Identifies and implements improvements to the QA Validation systems.
  • Participation in the change control program for modifications to qualified systems.
  • RVE responsibilities include the following: performance of detailed system review, generation of RVE documentation, scheduling & coordination of each RVE, performing and/or coordinating revalidation testing, completion of validation documents, etc.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

  • 3 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
  • Organizational and management skills to coordinate multi-discipline project groups
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!

Apply via this advert or contact Sarah Ninan at LSC on 021-4777329 if you have any more questions about this opportunity!

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
  • 95% of LSC contracts are renewed letting you choose contracting as a long term career option
  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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