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CQV Coordinator Pharmaceuticals

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Amaris Consulting

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Location:
Belgium , Beerse

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Category:
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Contract Type:
Not provided

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Salary:

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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.

Job Responsibility:

  • 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

Requirements:

  • 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
What we offer:
  • 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

Additional Information:

Job Posted:
March 04, 2026

Employment Type:
Fulltime
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