Quality Manager - CSV

Posted 05 September 2022
LocationNewry
Job type Permanent
Reference66122
Contact NameSarah Ghaziri

Job description

This is an opportunity working as a Quality Manager – CSV for a global pharmaceutical company who are committed to invest in their innovative and growing product pipeline.

 

This role will offer you:

  • To take complete ownership of GxP computer systems compliance for a global business
  • To act as their CSV subject matter expert in senior leadership meetings
  • To manage a small and growing quality team
  • Opportunity to work at the forefront of science with a global company who deliver pioneering products to the market which stand out from their competitors

 

You will be responsible for:

  • Providing leadership and support to the company with regards to CSV GxP compliance
  • Taking part in leadership meetings acting as the CSV SME - Providing expert input to support Operations, Qualification and Validation SOPs
  • Validation and qualification documentation for computer systems
  • Mentor and train your QA team within GxP CSV compliance

 

You will bring the following:

  • Extensive CSV GxP quality assurance experience
  • Strong working experience within a GMP and GLP regulated environment
  • Knowledge of GAMP and 21CFR Part 11 requirements is desired
  • Bachelor’s degree in a relevant Life Sciences subject