Senior QA Specialist, DPS (Drug Product Services) 80-100% (f/m/d)
Core
Represent Quality Assurance in cross-functional teams to oversee Drug Product manufacturing processes, approve GMP documents, and ensure shop floor compliance.
Role type
Senior QA Specialist (Drug Product Services)
Builds
Drug Product manufacturing processes and quality management systems
Domain
Pharmaceutical industry, Drug Product manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP environment experience, QA department experience, Chemistry/Biology/Biotechnology degree, deviation/change control/CAPA/investigation review, GMP document approval, batch record review, audit presentation, GXP training
Preferred skills
German language skills
Technologies
GMP, Good Documentation Practice, Good Aseptic Behavior
Responsibilities
Represent QA in cross-functional teams, act as point of contact for Drug Product QA issues, ensure manufacturing shop floor QA oversight, assess and approve quality records (deviations, change control, CAPAs, investigations), review and approve GMP-relevant documents, review and approve executed manufacturing batch records, present QA topics during internal and customer audits, provide GXP-related trainings, support continuous improvement programs
Seniority
Senior, hands-on IC
