This role has complete responsibility for the delivery of Quality Assurance and Regulatory Affairs for the affiliate.
Responsibilities will include:
- Representing the QA function within Quality leadership meetings, giving expert advice on strategies to maintain/improve quality performance
- Ensures that the Affiliate is in line with the European Guidance on Good Distribution Practise (GDP) for all relevant products
- Constantly improving the Pharmaceutical Quality System and product quality
- Regulatory compliance - write, review, develop, validate and maintain local regulatory SOPs in line with local regulatory legislation, guidelines, issues, practices and Corporate procedures
- Responsible for the management of release and updating of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL)
- Responsible for product recall
- Knowledge of Quality Systems Management, GDP, GMP, GCP, Regulatory and Pharmacovigilance legislation where appropriate
- Experience with CNS, gastroenterology or oncology would be an advantage.
- Effective investigations and analyses of issues are completed, and appropriate Corrective and Preventive Actions are identified and implemented
- Facilitates the conduct of Risk Assessments and the development of Risk Mitigation Plans, and monitors mitigation actions
- Launch, implements and manages a documentation system, able to fulfil legal and corporate requirements
For more information please get in touch with Natalie Hopkins via firstname.lastname@example.org or phone 0207 183 5059