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Compliance Specialist

  1. Ireland, Midlands (Ireland)
County Sligo
  1. Contract
Competitive
  1. Compliance / Quality Assurance
35145
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QA Compliance Specialist - Pharmaceuticals - County Sligo

Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a QA Compliance Specialist to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow.


Responsibilities:
  • Ensure that all products leaving Biologics Ballytivnan meet the standards required for marketed and investigational drug products.
  • Ensure that products and aseptic process simulations manufactured at Biologics Ballytivnan meet the requirements of the end users, regulatory authorities and of the company.
  • Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
  • Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.
  • Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
  • Review/Audit of completed Batch Records.
  • Review of Manufacturing Logs as required.
  • Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)
  • Completion of Line Clearance activities.

Requirements:
  • Third level degree in a science, quality or engineering discipline.
  • Ideally previous experience in a quality role
  • A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.
  • Experience in aseptic processing gained within either a quality or operations role is highly desirable.
  • A strong knowledge of regulatory requirements is required. 

If this role is of interest to you, please apply now! 

 #LI-JS4
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