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GMP Compliance Medior

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Amaris Consulting

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Location:
Belgium , Wavre

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Category:
-

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

Join our Operational Quality team to strengthen Environmental Monitoring (EM) and QA oversight across three GMP production buildings. You will design harmonized monitoring tools, lead inspection rounds, and author/review EM documentation to ensure robust compliance and continuous improvement.

Job Responsibility:

  • QA Oversight Design & Execution – Build and roll out oversight plans, workflows, and floor-level activities
  • secure complete, audit-ready documentation
  • Production Site Inspection Rounds – Schedule, conduct, and document joint inspections with production teams
  • drive rapid closure of gaps
  • EM Documentation Review & Alignment – Critically review risk assessments (RA) and SOPs
  • verify on-floor EM test adequacy and propose updates

Requirements:

  • University degree in Life Sciences (Bio-engineering, Biology, Biotechnology, Pharmacology, or similar) or equivalent experience
  • 4–6 years in a cGMP pharmaceutical/biotech environment, including ≥3 years focused on QA/EM activities
  • Solid grasp of EU/US GMP and regulatory expectations
  • Analytical, pragmatic problem-solver with strong influencing skills
  • Fluent English (written & spoken)
  • proven technical writing ability

Additional Information:

Job Posted:
February 14, 2026

Employment Type:
Fulltime
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