This is a permanent role for a Validation Lead, with a pioneering organisation in Stevenage that is expanding rapidly and will be moving to a new clinical manufacturing site later this year. We are looking for an adaptable, energetic, collaborative person to join this pioneering company who are at the forefront of T-cell therapy.
You will be paid a generous salary, annual bonus and healthcare, to discuss on application. You will be based primarily on site in modern premises in Stevenage, though there is flexibility for some home-based work.
Reporting to the QA Director, your role will include:
- Co-ordinating validation and technology transfer activities with sister sites, suppliers and third parties.
- Governing compliance with Validation Master Plan and QMS policies and standard operating procedures (SOPs)
- Generating validation plans, protocols and reports
- Project managing and executing validation exercises (facilities, equipment, process, analytical methods and computerized systems).
- Liaising with Production, Quality Control, Quality Assurance, Regulatory Affairs and Supply Chain providing as necessary to support compliance with GMP and regulatory requirements.
- Supporting QMS processes and taking part as required in supplier qualifications, deviation investigations, CAPA and change control implementations.
- Overseeing equipment maintenance and calibration schedules
- Supporting Quality Assurance team with general QA activities where required
- Providing training to site personnel
- Performing risk assessments and impact assessments
- Ensuring compliance and qualification of systems with respect to Data Integrity guidelines.
Skills and Experience Required:
- Experience of Validation (including CSV) gained within a commercial Pharmaceutical setting, ideally in a Biologics, Cell Therapy / ATMP, sterile manufacturing or Biopharmaceutical organisation, regulated to GMP standards
- Life science qualification – ideally a degree minimum in a biological discipline
- Experience of working with an eQMS processes (e.g. Trackwise, Veeva, MasterControl, Q-Pulse)
- Excellent communication skills and ability to work with people at all levels
- Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
Full details will be provided on application. This is a permanent role in Stevenage, Hertfordshire