Quality Assurance Manager

A popular biotechnological company are looking for Quality Assurance Manager to join their team working from home. This is a unique opportunity to join a company that can transform the clinical management of cancer

Job Responsibilities

• Deploy and maintain GxP Quality Management Systems with CMOs and Testing
• Laboratories to ensure compliance with regulations and inspection readiness at all times.
• Deploy and maintain a Quality Auditing capability with use of CAPAs to identify and track required improvements.
• Ensure that critical quality issues are reported to company management using the Global Quality alert process.
• Review and sign-off of master production, process validation and cleaning validation documentations provided by CMOs.
• Develop opportunities for improvement
• Support initiatives to meet or exceed Quality objectives.
• Contribute to continuous improvement planning and execution.
• Contribute to the deployment of the Global Technical & Quality roadmap for External Manufacturing.

Skills and Experience

• BSc or equivalent in a life sciences discipline, chemistry or biochemical engineering.
• 5 years hands-on experience gained in both Quality Assurance and Quality Control departments.
• Extensive experience of Internal & External Quality auditing, CAPA management,deviation management & risk assessments.
• Preparation for FDA and EMA inspections.
• Knowledge of biotech and aseptic manufacturing and processes, and product testing methods.

To Apply

In case you have difficulty in applying or if you have any questions, please contact Katty Maia on +44 203 854 3317 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

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