Senior QA Qualification Specialist (Manager) 80-100% (f/m/d)
Core
Own quality responsibilities for daily qualification activities of facilities, equipment, and systems related to cGMP manufacture of pharmaceutical drug products.
Role type
Senior QA Qualification Specialist (Manager)
Builds
Qualified state of facilities, equipment, and systems for pharmaceutical drug product manufacturing
Domain
Pharmaceutical manufacturing / cGMP compliance
Required skills
cGMP qualification expertise, deviation investigation, CAPA management, risk analysis (FMEA), SOP authorship, technical change assessment, regulatory inspection support, training delivery, audit representation
Preferred skills
Engineering/Chemistry/Biotechnology degree, pharmaceutical drug product industry experience, autonomous decision-making, cross-functional collaboration
Technologies
URS, Qualification Plans, DQ/IQ/OQ/PQ Reports, FMEA, Deviation Reports, CAPA, SOPs
Responsibilities
Compile and release qualification documents, assess technical change requests, support quality risk analysis, investigate deviations, drive CAPA completion, confirm qualified state during lifecycle, write/revise SOPs, represent qualification topics in audits, support cGMP training, mentor junior employees, identify non-compliance areas
Seniority
Senior, hands-on IC with management responsibilities
