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.
kevin.griffin@collinsmcnicholas.ie
021 2427108