CQV Coordinator Pharmaceuticals F​/M​/X

Job 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.

• 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)

• 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

• 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

• Coach qualification engineers on technical standards

• Provide onboarding training for new team members

• Serve as backup SME for colleagues during absences

• 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

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.

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines:
Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

We are proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.