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Quality Assurance - Pharmaceutical

  • Sector: Science & Pharma
  • Contact Email:
  • Job Ref: 22577

Fantastic opportunity to join a growing generic pharmaceutical organisation in Cork. The Quality Assurance/ Regulatory Affairs Specialist will be responsible for quality systems and quality assurance activities, compliance with cGxP’s, supporting the release of finished products and investigations of product-related issues. This role also offers a Hybrid working model.

Overview of Main Responsibilities (full job description available on request):

  • Ensures compliance with cGMP's & Environmental, Health & Safety regulations.

  • Ensure compliance & execute all activities to the Quality Management System, such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA

  • Executes the finished product non-conformance process.

  • Supports document reviews to ensure timely release of finished product.

  • Executes all regulatory updates to product labelling to ensure timely & compliant launch of finished products.

  • Manages & executes all routine regulatory updates & submissions of finished product labelling.

  • Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC)

  • Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.

  • Ensures the company and product are registered in the appropriate markets & with agencies as required.

  • Reviews and approves product labelling, patient package inserts and other product labelling.

  • Maintain familiarity with current regulatory trends.

  • Performs related duties as assigned.

What the ideal candidate looks like:

  • BSc in a scientific discipline.

  • Minimum of 5 years in a cGMP facility in a Quality Assurance role.

  • Experience in the Pharmaceutical industry is preferred.

What you will receive in return:

  • Competitive Salary

  • Pension

  • Healthcare

  • Bonus

For a confidential discussion and more information on the role, please contact Kevin Griffin.

021 2427108