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  • Location: Stevenage
  • Salary: Very competitive salary + bonus + healthcare
  • Job Type:Permanent

Posted about 1 month ago

  • Sector: Quality
  • Contact: Steve Twinley
  • Contact Email: steve.twinley@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2021-05-19
  • Job Ref: V-46863
A brand-new permanent role has been created for a versatile, hard-working Validation professional, to join a fast-growing cell therapy organisation in Stevenage, who are devoted to tackling cancer. Do you have strong Validation experience, including facilities, equipment, process, analytical method and computer systems validation (CSV)? If so, this will be a fantastic career opportunity, especially as you will be joining just before the company moves to a larger facility.
 
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