QUALITY MANAGER
Core
Ensure medicinal products are manufactured, tested, certified, and released in compliance with GMP regulations; act as key quality representative fostering quality culture.
Role type
Qualified Person (QP) / Quality Manager
Builds
Compliance and quality assurance for pharmaceutical manufacturing operations
Domain
Pharmaceutical manufacturing, GMP, Regulatory Affairs
Deliverable
production ML models
Required skills
GMP compliance, batch certification and release, deviation and CAPA management, regulatory inspection management, supplier audit management, quality systems oversight
Preferred skills
API environment experience, Deputy QP experience, negotiation and mediation
Technologies
AIFA regulations, GMP standards
Responsibilities
Perform batch certification and release, manage deviations/CAPAs/complaints, lead regulatory inspections, support internal/external audits, ensure ongoing GMP compliance
Seniority
Senior, 7-10 years experience, potential to grow into autonomous QP
