Spécialiste Assurance Qualité - Référent PQR - H/F
Core
Ensure pharmaceutical production activities comply with regulations and Good Manufacturing Practices (GMP) by supervising the Process Qualification Report (PQR) process, conducting audits, and managing quality incidents.
Role type
Quality Assurance Specialist (Pharmaceutical Manufacturing)
Builds
Process Qualification Reports (PQR), quality compliance documentation, and risk management strategies for production.
Domain
Pharmaceutical industry, Manufacturing (via careerplan.io/jobs/2819328-specialiste-assurance-qualite-referent-pqr-hf)
Required skills
GMP compliance, PQR process management, root cause analysis, audit execution, risk management, performance indicator analysis, corrective and preventive action (CAPA) implementation, stakeholder coordination.
Preferred skills
English writing skills, proactive problem-solving, strategic quality planning.
Technologies
None stated
Responsibilities
Supervise the PQR process including data collection and documentation; conduct regular production process audits; manage and resolve quality-related issues; lead root cause investigations for quality incidents; monitor quality performance indicators; support internal and external regulatory inspections; develop risk management strategies; ensure adherence to GMP regulations.
Seniority
Mid-level, hands-on IC
