Computer System Validation (CSV) Manager

  • Michael Page
  • Nov 04, 2021
Full time Information Technology Telecommunications

Job Description

The client are a rapidly expanding biopharmaceutical company developing groundbreaking immunotherapy treatments in the field of oncology. They have recently undergone significant investment and are looking to better develop their systems, processes and drive improvement forward within the business.

Job Description
As a CSV Manager you will:
  • Plan and perform validation activities relating to systems, processes, data audits and inspections
  • Play a key role in the development of internal controls and processes relating to compliance
  • Review / approve key validation deliverables of computer-based software
  • Document audit findings and recommendations and identify process improvement initiatives
  • Prepare reports to for internal and external stakeholders on quality related matters, risk assessments and specific quality improvement initiatives
The role can be flexible offering the ability to work on-site or remotely as required.

The Successful Applicant
As an ideal candidate, you will have:
  • Strong knowledge and understanding of industry regulations (21 CFR Part 11, annex 11 and GAMP) (essential)
  • Extensive validation / CSV experience within the pharmaceutical discipline (essential)
  • Experience of supporting audits from external bodies (suppliers, regulatory bodies etc) (essential)
  • Knowledge of a range of programmes including: Sharepoint, Docusign, LIMS, eQMS, RIMs (desirable)
  • Excellent interpersonal skills
What's on Offer
The company are offering a flexible approach to the role looking for either a contractor or permanent candidate to join the team through an extremely exciting growth period.

Contact
Jason Hines

Quote job ref
JN-102934

Phone number