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Permanent

Quality Manager/Responsible Person - Pharmaceuticals

Gloucester
money-bag 10000-500000 Annual
Posted 1 week ago

Quality Manager/Responsible Person - Pharmaceuticals - GloucesterSmart4 Sciences are proud to partner with an established and internationally recognised pharmaceutical company, renowned for their focus on the development, licensing and distribution of high-quality injectable medicines. With almost five decades of trusted service supplying the NHS, private healthcare, and global markets, they continue to lead in injectable and infusion therapiesWe''re now supporting them in hiring an experienced Quality Manager/Responsible Person (RP) to lead and continually improve the UK Quality Management System, uphold licence compliance, and embed GDP and ISO9001 best practice across their UK wholesale distribution operations.Key Responsibilities:Manage and develop the UK Quality Management System (QMS) and eQMS, ensuring documentation, policies and procedures remain compliant and effective.Maintain WDA(H), GDP and ISO certifications; host regulatory inspections and manage responses through to closure.Oversee internal audits, supplier audits and self-inspections, driving continual improvement.Serve as an additional Responsible Person on the WDA(H) licence, ensuring ongoing compliance with GDP and regulatory expectations.Lead investigation, change control and CAPA activities, applying ICH Q9 Quality Risk Management principles.Champion GDP culture, deliver training, and promote quality awareness across the organisation.Manage quality complaints and communication with the MAH and ..... full job details .....

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