Expert Laboratoire Contrôle Qualité (F/H/X)
Core
Analytical quality control support for on-site and off-site production activities, ensuring data integrity and compliance with GMP standards for active substances and stability studies.
Role type
Senior Quality Control Laboratory Analyst (Analytical)
Builds
Production batches and stability study reports for pharmaceutical/biotech products
Domain
Pharmaceutical/Biotechnology, Analytical Chemistry/Biology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, OOS/OOT investigation management, CAPA implementation, stability study protocol review, LIMS usage, analytical method validation knowledge, GMP/cGMP compliance, risk analysis
Preferred skills
Biological/biochemical analysis expertise, documentation improvement, cross-functional coordination with external labs
Technologies
LIMS, document management systems, deviation management software
Responsibilities
Review and approve raw data generated by QC teams, manage OOS/OOT investigations including root cause analysis and corrective actions, oversee outsourced analytical activities and external lab coordination, conduct stability study protocol reviews and report generation, generate and implement CAPAs to reduce quality risks, participate in procedure and risk analysis reviews
Seniority
Mid-Senior, hands-on IC