Quality Assurance Role Cork

QA Validation Associate

  • Posted Aug 17, 2023
  • Cork
  • Contract
  • BBBH26815

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.


  • Provide project management oversight for FUE activities related to products and facilities, utilities, equipment (FUE).
  • Developing validation plans for specific system implementation projects.
  • Performing and reviewing (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
  • 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 validation techniques/approaches and systems utilized
  • Lead and represent Validation in multi-departmental meetings & project teams.


  • 10 years minimum demonstrated Project Management, cross-functional Team Lead and Delivery experience in a commercial GMP Secondary Packaging/Labelling/Serialisation Environment.
  • Demonstrated SME/Technical Experience with ownership of all packaging related deliverables within similar organisation.
  • Strong demonstrated Leadership, Verbal and written communication skills with ability to effectily communicate at multiple levels across the organisation.

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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