Quality Manager - CSV

Posted 04 September 2022
LocationNewry
Job type Permanent
DisciplineQuality
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