The company is creating cutting – edge therapies to help change people’s lives in their state-of-the-art GMP manufacturing facility in Edinburgh.
The role comes with a competitive salary and excellent benefits that can be discussed on application.
The Role:
You will be responsible for overseeing and improving the sterility assurance programme ensuring it meets all aspects of international aseptic processing requirements.
Key Responsibilities:
- Review procedures to assure best industry practice in respect to material handling and transfer, operator training, cleaning and aseptic practices, aseptic process simulations, filter integrity testing, cleanroom behaviours, environmental monitoring and microbial control.
- Provide oversight and expertise to the sterility assurance programme.
- Lead the design, review and update of contamination control strategies.
- Apply quality risk management principles to evaluate and control all aspects of the sterility assurance of products and processes.
- Manage and monitor of the cleaning and disinfection programme.
- Provide advice and guidance on environmental monitoring and sterility assurance related investigations and CAPAs.
- Review of changes impacting sterility assurance.
- Supporting of regulatory and client audits as the aseptic sterility assurance subject matter expert.
- Development of a comprehensive knowledge-based sterility training programme encompassing both aseptic procedures and cleanroom behaviours including new start training, training resources, refresher training and knowledge checks and a coaching programme.
Experience:
- You will have a Life Science degree (HND, HNC or BSc) and experience working in a GMP environment in a pharmaceutical or biopharmaceutical company.
- You will have strong knowledge of microbiology, sterility testing, media fills/simulations, environmental monitoring, cleanroom qualification/management and microbiological control strategies.
- You will have experience in sterile aseptic processing and the associated regulations.
- Experience in cell culture and cell and gene therapy would be desirable, although not essential.