Quality & Regulatory Specialist

Reporting to the Quality & Regulatory Manager, you will be primary responsible for quality systems and quality assurance activities, compliance with cGxP’s, in addition support release of finished products.

Role Responsibilities:

• Ensures compliance with cGMP's & Environmental, Health & Safety regulations.
• Ensure compliance & execute all activities to the BluePoint Laboratories 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.
• Executes the document control system & record retention.
• Develops, implements and maintains Standard Operating Procedures. 
• Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement.
• Maintain familiarity with current regulatory trends.
• Establishes and promotes the maintenance of a safe, accident free and healthy work environment.
• Performs related duties as assigned.

Role Requirements:

• BSc in a scientific discipline (or equivalent plus experience); minimum of 3-5 years in a cGMP facility in a Quality Systems/Quality Assurance Operations role. 
• Essential to have good communication and attention to detail.
• Experience in the Pharmaceutical industry is essential.  
• Excellent knowledge of Quality Systems, Quality Assurance, and cGxP.

For a confidential discussion and more information on the role, please contact Josh Barnes.

josh.barnes@collinsmcnicholas.ie

021-4911066