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Regulatory Compliance Expert

3 weeks ago

Sligo, Sligo, Ireland PE Global Full time
Role Summary:

This is an exciting opportunity for a Quality Assurance Compliance Specialist to join our team in Sligo.

Key Responsibilities:

  • Ensuring that all products leaving site meet the required standards for marketed and investigational drug products.
  • Providing quality and compliance oversight and assistance to the Operations function to manufacture products in compliance with site policies and procedures.
  • Leading investigations arising out of product or manufacturing processes non-compliance.

Requirements:

  • Third level degree in a science, quality or engineering discipline.
  • 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.