Specialist (m/w/d) Quality Oversight Quality Control
Core
Central interface between Quality Control and Quality Assurance ensuring GMP compliance and effective Quality Oversight in sterile injectable drug manufacturing.
Role type
Specialist, Quality Oversight
Builds
Sterile injectable pharmaceuticals (oncology therapeutics) and related services
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP knowledge, aseptic manufacturing knowledge, trend analysis, data integrity management, audit support, corrective and preventive action development, on-site coaching
Preferred skills
Degree in Chemistry, Pharmaceutical Technology, Biotechnology, Pharmacy, or Food Technology, multi-year laboratory experience
Technologies
GMP, aseptic manufacturing
Responsibilities
Conduct regular inspections in Quality Control areas focusing on data integrity and lab processes; Document, track, and evaluate observations from inspections and GMP audits; Analyze trends to identify performance gaps and develop improvement measures; Support regulatory and customer audits; Detect quality risks early; Coach and support employees on the job site; Promote and ensure high data integrity; Contribute to continuous improvement processes
