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Quality Assurance Professional

2 weeks ago

Sligo, Sligo, Ireland beBeeRegulation Full time €75,000 - €95,000

As a Quality Assurance Specialist, you play a crucial role in ensuring the quality and safety of manufactured products.

About This Role

This is a 12-month contract position that requires a high level of expertise in pharmaceutical manufacturing practices.

Key Responsibilities:
  • Comply with EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release;
  • Ensure each batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place;
  • Verify products are manufactured in accordance with relevant GMPs;
  • Disposition bulk product manufactured at site as acceptable for release or reject based on information available relating to manufacture and testing of product;
Requirements:
  • Third-level qualification in science discipline with 5 years experience in pharmaceutical industry;
  • MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person status;
  • 5 years industrial experience gained in FDA and EMEA approved pharmaceutical environment;
  • 2 Years experience gained within aseptic processing environment, ideally gained within quality function;