C & Q Project Coordinator

C&Q Project Coordinator

Profile & Mission

- Accountable for the performance of operations and/or support within the organisational division.
- Provide support to project team for C&Q coordination (FAT/SAT/IQ/OQ).
- Description In the context of investments projects (new or upgrades) in 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 advise the various actors in case of issues or deviations
- Has an expertise in all commissioning/qualification aspects of 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 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
- Good knowledge in coordination of activities,
- Good expertise in GMP Practices (V cycle,&)
- Ability to work in project teams in a multidisciplinary environment and a metrical organization -
- Quality oriented

Regulations and standard guidelines:
cGMP Specific regulations and guidelines applicable to the pharmaceutical industry ICH Q9 on Quality Risk Management

Required experience:

- Between 3- 8 years experience in a similar position in the pharmaceutical industry
- Have already demonstrated success in C&Q coordination in projects
- SAP
- Microsoft Office Languages skills
- Fluent in English & French