Job description
Mission description:
We are looking for a CQV manager to provide documented evidence that all equipment and utilities used in IM SC are qualified and remain in a state of control, ensuring processes and products meet regulatory and business specifications.
Key Responsibilities
Technical Leadership
* Coordinate qualification activities for assigned projects/changes/modifications
* Own technical content of Equipment Qualification files (URS, SRS, SIA, CARA, DQ, QP, IQ, OQ, PQ, QSO)
* Act as Technical Owner within the organization
* Review and approve qualification documents in KNEAT (paperless system)
Project Management
* Lead core team/planning meetings for assigned projects
* Maintain Kanban cards for work overview
* Manage test planning, materials, and resources with cross-functional teams
* Ensure timely, qualitative execution of qualification activities
Quality & Compliance
* Ensure GMP compliance throughout qualification lifecycle
* Identify gaps in procedures/files and propose improvements
* Initiate non-conformance reports in COMET
* Support internal/external inspections and maintain Validation Master Plans
Team Development
* Coach qualification engineers on technical standards
* Provide onboarding training for new team members
* Serve as backup SME for colleagues during absences
Required Profile
* Experience: 5+ years in pharmaceutical GMP environment
* Technical Expertise: Aseptic/sterile equipment and processes
* Education: Technical-scientific degree preferred
* Languages: Fluency in English is mandatory and Dutch is a strong advantage.
* Systems: KNEAT experience preferred
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.