Job description
Mission
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.
Key Responsibilities
• 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.
Must-Have Profile
• 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
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.