Description
Our client, a multinational company in the pharmaceutical industry requires a Commissioning & Qualification Project Manager to reinforce their project team for C&Q coordination
Start: ASAP
Length: 6 months
Location: South of Brussels
Tasks:
Operations delivery is accountable for the performance of operations and/or support within the organisational division concerned.
Provide support to project team for C&Q coordination(FAT/SAT/IQ/OQ).
Description:
- In the context of investments projects (new or upgrades) in vaccines production, ensure proper execution of the 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 (chromatography systems, fermentor) and 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.
- 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.
Education:
- Have a scientific degree (Chemistry, Biochemistry, ...) or equivalent by experience
Knowledge/Skills:
- 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 skills and competencies level in C&Q activities: organization, understanding and implementation of C&Q practices in projects, time schedule, team working,
- Coaching and communication skills (FR & EN)
- Good knowledge in coordination of activities
Mots clé: Commissioning and Qualification, C&Q, Calibrage etmesures, HVAC, CIP, SIP, Clean Utilities, Nettoyage