TASKS & RESPONSABILITIES
Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now.
In the context of investments projects (new or upgrades) in vaccines production, ensure proper execution of 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.
- Must be able to advice the various actors in case of issues or deviations .
- Has an expertise in all commissioning / qualification aspects of vaccine manufacturing such as 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 equipments other equipment commonly used in vaccine manufacturing facilities and be able to manage most of these qualification aspects.
- Ensure that all GMP aspects are respected during the project. xlxgzvr
- 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.
YOUR PROFIL
- Have already demonstrated success in C&Q coordination in projects
- Over 3 years’ experience in C&Q in pharmaceutical area
- Bilingual French/English (written and spoken)
- Good experience in managing qualifications projects
- Good understanding of the injectable manufacturing processes
- 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 equipments (chromatography systems, fermentor, …)
- Planning of activities
- Good expertise in GMP Practices (V cycle, …)
- Ability to work under heavy pressure due to the requested flexibility and reactivity of the activities
- Ability to work in project teams in a multidisciplinary environment and a matricial organization
- Quality oriented
C&Q ENGINEER PHARMA H-F • Mons, Belgium
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