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Quality & Regulatory Specialist | Cork

  • Sector: Science & Pharma
  • Contact Email:
  • Job Ref: 19738

Quality & Regulatory Specialist | Cork

Fantastic opportunity to join a growing generic pharmaceutical organsiation in Cork. The Quality & Regulatory Specialist will be responsible for quality systems and quality assurance activities, compliance with cGxP’s, supporting 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 is registered in the appropriate markets & with agencies as required.
  • Reviews and approves product labeling, patient package inserts and other product labeling.
  • 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 get in return:

  • Competitive Salary.
  • Pension.
  • Healthcare.
  • Bonus.

For a confidential discussion and more information on the role, please contact Aisling Lane.

(021) 4320675