Quality Assurance Role Cork

Quality Systems Specialist

  • Posted Jul 1, 2024
  • Cork
  • Contract
  • BBBH27677

LSC have a great contract opportunity for a Quality System Specialist 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.
If you have 10 years of experience in Quality Management Systems within a GMP environment and are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • Conducting a comprehensive gap analysis of our current QMS against relevant standards and various health authority regulations for different phases in Clinical GMP Manufacturing across various modalities.
  • Identifying areas of non-compliance and opportunities for improvement.
  • Draft SOP to implement the new efficient processes.


ABOUT YOU - ARE YOUR SKILLS A MATCH?

  • Quality management Systems (QMS) SME
  • Troubleshooting failures and review/approval of supporting documentation.
  • Identifying opportunities for improvements to QMS.
  • 10 years' QMS experience within a GMP environment.
  • BSC in Science/Engineering


Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Gráinne Hodnett 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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