Qualified Person Role Tipperary

Qualified Person

  • Posted Sep 29, 2021
  • Tipperary
  • Contract
  • BBBH24494


LSC have a great contract opportunity for a Qualified Person to join a top 10 Pharmaceutical company based in Tipperary.

If you have proven experience within the Pharmaceutical industry in a leading QA/QC/Compliance role and are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • Ensure that the batch has been manufactured and tested in accordance with current GMP Guidelines Directive 2003/94/EC, EC Guide to GMP for medicinal products and/or the FDA Code of Federal Regulations.
  • Ensure that the batch is released according to the relevant Annex to the Rules and Guidance for Pharmaceutical Manufacturers and Distributors. In particular Annex 13 - Investigational Medicinal Products and Annex 16 - Certification by a Qualified Person and Batch Release.
  • Ensure that the principal manufacturing and testing processes have been appropriately validated and that account has been taken of the actual production conditions and manufacturing records
  • Application of Quality Risk Management to all process and systems.
  • Production support and quality compliance guidance to ensure the facility meets and operates to all GMP requirements for development, clinical and commercial supply.
  • Assist the IPT leadership team to deliver business results for the IPT in line with overall site goals


ABOUT YOU - ARE YOUR SKILLS A MATCH?

  • Qualified Person status achieved with relevant working experience acting as Qualified Person named on a Manufacturing & Importation Authorisation (MIA).
  • Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, LIMS, QSAT, Quality Docs).
  • Knowledge and demonstrated expertise in Lean / Continuous Improvement.
  • Experience and knowledge of GMP Requirements for Electronic/paper free operations.


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 Pawel Jurkiewicz at LSC on 021-4777329 if you have anymore questions about this Qualified Person opportunity!

This could be the perfect project for you! Apply online and we’ll be in contact shortly

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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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