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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