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.
- 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.
- 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.