Senior Supervisor (m/w/d) QC Routine Labor Team II
Core
Leading and developing a QC routine labor team to ensure timely finalization of product and stability analytics, conducting investigations for OOS/OOE results, and managing deviations/CAPAs.
Role type
Senior Supervisor (QC Routine Labor Team II)
Builds
Product and stability analytics, GMP-compliant documentation, and regulatory reports
Domain
Pharmaceutical Quality Control / Analytical Chemistry
Required skills
GMP compliance, regulatory knowledge (ICH, EU-GMP, Ph. Eur./USP), analytical data evaluation, team leadership, budget planning, Lean principles implementation
Preferred skills
Change management, continuous improvement, stakeholder communication
Technologies
MS Office
Responsibilities
Disciplinarily lead and develop team members, ensure timely finalization of product and stability analytics, conduct investigations for OOS/OOE results and deviations, approve test protocols/reports and release/reject raw materials and packaging materials, support customer audits and inspections, ensure GMP-compliant work methods, create and review GMP documents (SOPs, plans, reports), provide expert advice and communicate with internal/external interfaces, support resource and budget planning, implement Lean principles and promote continuous improvements
Seniority
Senior, hands-on IC with leadership responsibilities