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
- 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.
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.