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Expired
  • Location: London
  • Salary: Highly Competitive Salary + Excellent Benefits
  • Job Type:Permanent

Posted 2 months ago

  • Sector: Quality
  • Contact: Irish Leyso
  • Contact Email: irish.leyso@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2022-11-25
  • Job Ref: V-47624
Have you got CSV experience in a GxP environment? Do you have experience in managing and leading a small team? If so, this could be an excellent opportunity for you.
 
This is an exciting opportunity for an experienced CSV specialist to join a market leading clinical-stage gene therapy company that are developing potentially curative therapies for people suffering from serious diseases. Along with a vast pipeline of preclinical and research activities, they have six clinical programmes in development. They have offices in USA , London, and a large manufacturing facility in Ireland, their geographical footprint provides them with the opportunity to partner with globally leading institutions and attract the best talent across the world.

The Role:
  • Implementing, developing, and managing compliance-related electronic systems.
  • Ensuring computerised systems are implemented, maintained, and operated in accordance with EU/Annex 11, GAMP, FDA/21 CFR Part 11, Data Integrity GxP requirements and all other applicable regulations.
  • Supporting the evaluation of systems and internal audits for processses involving computer systems.
  • Ensuring system reviews are performed and upgrades are managed.
  • Supporting QMS activities as needed.
  • Managing and leading a team with all aspects of the HR process including recruitment, onboarding, mentoring, performance management and employee development.
Knowledge/Skills Requirements
  • Degree educated in Human Health, Sciences or equivalent.
  • 5+ years experience with CSV and IT compliance in a GxP environment.
  • Experience in implementing, managing and operating IT systems, especially eQMS.
  • Knowledge of GxP regulations and policies related to verification and operation of computer systems.
Further information regarding this position will be disclosed on the initial screening call.

Please note that this role will not offer sponsorship - all candidates must have the RTW in the UK.