Quality Assurance Manager

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Quality Assurance Manager Are you an experienced Quality Assurance Manager looking for a new exciting job opportunity? Our client is looking for Quality Assurance Manager the primary function is to lead the QA team on further developing the Quality Management System and managing the Quality Assurance requirements of the company, thereby ensuring compliance with the necessary legislation. The principal objective is to ensure that the cell and gene therapies and stem cell banks manufactured fully comply with the requirements of Good Manufacturing Practice (GMP) and meet the various applicable regulatory standards. The responsibilities:
• Ensuring that all direct reports are trained in GDP and GMP and all relevant procedures
• Performing internal and supplier audits
• Maintain the MS in conjunction with the licence holder
• Providing QA oversight at site
• Ensuring changes are appropriately documented, reviewed, approved and controlled
• Being responsible for Quality within the site and named as QC on respective authorisations
• Ensuring documents are managed, approved and controlled
• Maintaining knowledge of applicable regulations To be eligible for the role, you will need to:
• Thorough knowledge of GDP and GMP regulations
• Knowledge of pharmaceutical regulatory framework within UK
• Batchelors degree (or higher) in Life Sciences or related subject
• Proven experience in Quality Assurance gained within a CRO or Pharma environment and thorough understanding of GCP compliance and Quality management
• Strong knowledge of ICH and GCP and proven experience of audits and inspections
• Excellent communication, leadership and influencing skills
• Eligibility to live and work in the UK You will enjoy the following benefits:
• Considerable scope for progression in a fast moving industry
• Generous employer pension contribution scheme
• Competitive bonus scheme
• On-site parking
• Quick registration process
• Dedicated consultant and support 24/7 THE DETAILS: Location: Cambridge Job-Type: Perm Salary: Negotiable TTM Healthcare is an Equal Opportunities Employer Please contact Klaudia Kmita-Adegboro at 44 (0) (phone number removed) ext 131

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