Qualified Person - Germany
Core
Qualified Person responsible for batch release approvals and quality management in a pharmaceutical manufacturing context.
Role type
Senior Quality Management Qualified Person (Pharmaceuticals)
Builds
Pharmaceutical products (generics, medical devices, biopharmaceuticals)
Domain
Pharmaceuticals / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GDP expertise, Deviation Management, Product Quality Reviews, New Product Introductions, Supplier Evaluation, Regulatory Inspection Support, Team Leadership, Process Improvement
Preferred skills
SAP, MS Office, Pharmaceutical-specific software
Technologies
SAP, MS Office
Responsibilities
Ensure batch release approvals per § 14 AMG, lead and coach a small team of 2, manage quality system processes, act as interface with contract manufacturers, support regulatory inspections and audits.
Seniority
Senior, hands-on IC with team leadership