Commissioning & Qualification Projects Coordinator
Walloon Brabant – contracting
#Pharma #Commissioning #GMP #Qualification #Validation
Our partner is looking for a Commissioning & Qualification Projects Coordinator to join its team. Our partner is well known for its pharmaceutical and vaccines.
- In the context of investments projects (new or upgrades) in vaccines production, ensure proper execution of the company C&Q methodology and application of cGMP (Validation Master Plan, Design Qualification, Commissioning, Installation & Operational Qualification and Validation Reports).
- Follow and coordinate the commissioning and qualifications during a project
- Review and ensure the compliance of the qualification protocols, review the commissioning and qualification raw data and finally approve the reports for conformance
- Participation in the overall commissioning strategy in close collaboration with all partners
- Participation in the overall qualification strategy
- Must be able to advice the various actors in case of issues or deviations
- Ensure that all GMP aspects are respected during the project.
- Able to manage the project respecting the established commissioning / qualification timelines and coordinate all actors (Contractors, Engineering, Users) to align them with the project planning.
- You have over 3-5 years experience in Commissioning & Qualification in pharmaceutical area
- You have good experience in managing qualifications projects
- You are bilingual French/English (written and spoken)
- You have good understanding of the injectable manufacturing processes
- You have knowledge in qualifications of HVAC systems, Clean Utilities (Clean Compressed Air, Clean Steam, Purified Water, Water For Injection, …), autoclaves, analytical systems, CIP/SIP process, filling lines, bulk equipment's (chromatography systems, fermentor, …)
- Planning of activities skills
- Good expertise in GMP Practices
- You are quality oriented
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply.
Do you have any questions? You can contact Anaïs Malikian, [email protected]