QA PCU Leader Compounding
Core
Lead the Quality Assurance team for the compounding service, ensuring aseptic filling solutions and materials meet strict quality standards and GMP compliance.
Role type
Senior Quality Assurance Team Leader (Pharmaceutical Manufacturing)
Builds
Aseptic filling solutions and materials for pharmaceutical products
Domain
Pharmaceutical manufacturing / Aseptic processing
Required skills
GMP compliance, Quality Assurance principles, Data analysis, Team leadership, Project management, Root cause analysis, Continuous improvement, Audit management, Cross-functional collaboration, Sterility and cleaning standards
Preferred skills
Master's degree in Quality Assurance, Engineering, or Pharmacy, English fluency
Technologies
GMP, CAPA, Deviation management, Quality indicators
Responsibilities
Lead and develop the compounding service QA team, supervise daily QA activities for aseptic filling, manage quality events (deviations, CAPA, change controls), analyze quality performance indicators, collaborate with production on sterility and cleaning standards, participate in internal and external audits.
Seniority
Senior, hands-on IC with management responsibilities