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  • Location

    Netherlands

  • Job title:

    Quality Management Owner

  • Sector:

  • Job ref:

    46833

  • Start Date:

    2021-11-01

Quality Management Owner

The company

My client is one of the biggest Biopharmaceutical companies in the world and they strive to serve patients with the highest quality. They focus on serious diseases that have little to no cure and distribute their medicine to hospitals and pharmacies in over a 100 different countries. Numerous lives have been prolonged and saved with the use of their therapies and medicine. This company combines science and entrepreneurship and their culture makes it a special place to work. Are you ready to join? They are based in the Noord-Brabant region.

Role
You will be responsible for owning change control/NC/CAPA records via Trackwise. You will also facilitate and lead RCA’s to resolve issues through expertise in problem-solving methodology. Review for completeness of actions and records.

Responsibilities
- Ensure compliancy and effectiveness of the records
- Coach CCMS owner teams in problem-solving techniques and promote it’s development (human error reduction, 4-D, 5 Why’s, fishbone diagram, process mapping)
- Cooperate with other sites of the company to ensure compliance to global requirements are achieved


Requirements
- At least a Bsc. degree
- At least 1 year experience with Change NC/CAPA programs in a GMP environment
- Six Sigma Green or Black belt
- Knowledge or regulations Eudralex Annex 15, FDA CFR 11, 210 and 211


Other information
For this role a EU passport or VISA for Europe is required. No Intercontinental sponsorship possible. Are you ready to take a new step in your career? If you are interested or know someone who is interested, please contact Leslie Fraser or upload your resume using the apply button.

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804