Pharmacien Assurance Qualité & PRI F/H
Core
Interim Quality Manager responsible for regulatory compliance and quality management system in a pharmaceutical manufacturing setting.
Role type
Senior Quality Manager (Interim)
Builds
Pharmaceutical products under regulatory oversight
Domain
Pharmaceutical industry, Quality Assurance, Regulatory Affairs
Required skills
Regulatory compliance (Code de la Santé Publique), Quality Management System (SMQ) maintenance, Deviation/CAPA/Change management, Pharmacovigilance supervision, Regulatory lifecycle management (AMM), Stakeholder interaction with health authorities
Preferred skills
Master's degree in Regulatory Affairs or Quality, English fluency (written and oral)
Responsibilities
Ensure compliance with regulatory obligations for the operator status, Contribute to the maintenance and improvement of the Quality Management System, Participate in quality activities management (deviations, CAPA, changes, complaints, audits), Intervene on regulatory activities including AMM lifecycle tracking, Supervise pharmacovigilance and medical information activities, Control promotional activities, Assist and replace the Responsible Pharmacist
Seniority
Senior, hands-on IC