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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