QA & Reg Specialist

Excellent opportunity to join an expanding quality team within a leading Pharmaceutical company. Reporting to the Quality & Regulatory Manager, you will be 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. PRIMARY DUTIES AND RESPONSIBILITIES:
1. Ensures compliance with cGMP's & Environmental, Health & Safety regulations.
2. Ensure compliance to Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA
3. Executes the finished product non-conformance process.
4. Supports document reviews to ensure timely release of finished product.
5. Executes all regulatory updates to product labelling to ensure timely & compliant launch of finished products.
6. Manages & executes all routine regulatory updates & submissions of finished product labelling.
7. Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC)
8. Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
9. Ensures the company and product is registered in the appropriate markets & with agencies as required.
10. Reviews and approves product labeling, patient package insert and other product labeling.
11. Executes the document control system & record retention.
12. Develops, implements and maintains Standard Operating Procedures.

Experience

Minimum requirement of a BSc in a scientific discipline; minimum of five (5) 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 regulations is desirable but not essential.
Excellent problem-solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
Ability to apply critical thinking on review of all quality related procedures and documents
Knowledge of Quality Systems, Quality Assurance, cGxP and regulatory affairs
Computer literate; Excel, Word, Document Management System, etc..