Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a Commissioning & Qualification Support
Start: ASAP
Length: min 4 months with a possibility of being extended
Location: South of Brussels
1) Tasks:
- 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).
- 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 aproject
- 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 actorsin 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 able to manage most ofthese qualification aspects. Ensure that all GMP aspects are respected during the project. Able to manage the project respecting theestablished commissioning/qualification timelines and coordinate all actors (Contractors, Engineering, Users) to align them with the project planning.
2) Deliverables of the Mission:
- Phase PQ
- Provide support to project team for C&Q coordination (FAT/SAT/IQ/OQ) with a focus on PQ activities
- 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) with a focus on PQ activities (PQ Master Plans and Reports).
3) Profile:
- Good expertise in GMP Practices (V cycle)
- Ability to work under heavy pressure due to the requested flexibility and reactivity of the activities
- Autonomous
- Ability to work in project teams in a multidisciplinary environmentand a matricial organization Quality oriented
4) Regulations and standard guidelines:
- cGMP Specific regulations and guidelines applicable to the pharmaceutical industry ICH Q9 on Quality Risk Management
5) Required experience:
- Have already demonstrated success in C&Q coordination in projects
- Over 5 years experience in C&Q in pharmaceutical area IT skills
- SAP
- Microsoft Office
6) Languages skills
- English
- French
Tags: Commissioning, Qualification, C&Q, pharmaceutical, CIP, SIP, PQ