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