Quality Assurance Manager

Walker Cole International have been appointed to search for a Quality Assurance Manager for a Pharmaceutical Business as they look to expand their established European Quality Team. This role will be responsible for leading a QA Team and ensuring GMP compliance is maintained in accordance with MHRA and EMA standards. 

Your responsibilities will be to:

• Maintain and improve a Quality Management System for GMP compliant Suppy and product launch activities, including CAPA's Deviations, Product Quality Reviews (PQR's).
• Manage Supplier Quality network including CMO's (Contract Manufacturing Organisations), including review of stability protocols, batch manufacturing records and validation documents.
• Support the Commercial Team with Due Diligence assessments prior to acquisition.
• Conduct both internal and external audits and be involved in regulatory inspections including MHRA and EMA in accordance to Good Manufacturing Practice (GMP).

 The successful candidate will have:

• Extensive experience in Quality Assurance within the Pharmaceutical industry on a Manufacturing site.
• Experience managing a Quality Management System, and External Quality Network including CMO's (Contract Manufacturing Organisations).
• Knowledge of UK, EU and US guidelines and standards 

 eQMS | Quality Management System | QMS | European Directive 2003/94/EC for Good Manufacturing Practice | Good Distribution Practice of Medicinal Products for Humans 2013/C 343/01 | Good Manufacturing Practice | GMP | CAPA | Corrective and Preventive Action | Audit | MHRA | EMA | Due Diligence | Batch Manufacturing Records | Validation Documents | Stability Protocols | Product Quality Reviews | CAPA | Contract Manufacturing Organisation | CMO | Quality Assurance | Quality