Location: Cork Role: Permanent
Quality & regulatory Specialist, reporting to the Quality & Regulatory manager responsible for quality systems and quality assurance activities, compliance with cGxP’s, in addition support release of finished product and investigations of product related issues and regulatory affairs.
• 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 insert and other product labeling.
BSc in a scientific discipline preferred with a minimum of 3 years in a cGMP facility in a Quality Assurance role. Essential to have good communication and attention to detail.
Experience in the Pharmaceutical industry is essential. Experience in Medical Device & Pharmaceutical regulations is desirable.
• Artwork review/Regulatory experience desirable
• Computer literate; Excel, Word, Document Management System, etc..
• Excellent knowledge of Quality Systems, Quality Assurance, cGxP and regulatory affairs