Quality Assurance & Regulatory Affairs Officer - Pharmaceuticals

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 natalie@linkfieldgroup.com or phone         0207 183 5059

• Life Sciences Degree