RESPONSABLE AQ EXPLOITANT & DISTRIBUTION INTERNATIONALE
Core
Ensure regulatory and operational compliance for the operating site's Quality System and international pharmaceutical distribution activities.
Role type
Senior Quality Assurance Manager (Pharmaceutical Operations & Distribution)
Builds
Pharmaceutical distribution networks and quality management systems
Domain
Pharmaceutical industry / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical Quality System management, Audit techniques, Project management, Regulatory vigilance, Batch tracking, Medical device promotional information oversight, International distribution quality system management
Preferred skills
MDR 2017/745 knowledge, ISO 13485 knowledge
Technologies
BPF, BPD, BPPV, MDR 2017/745, ISO 13485
Responsibilities
Lead the operating site Quality System (management reviews, quality committees, audits, CAPA, complaints), Ensure compliance of product distribution with distributors and transporters, Supervise medical device promotional information activities, Manage the International Distribution Quality System (requirements for subsidiaries/distributors, audits, serialization, anomalies), Participate in relevant projects, Ensure regulatory vigilance
Seniority
Senior, hands-on IC
