Qualified Person - Germany
Core
Ensure batch releases and lead a small team to maintain quality management systems and processes in a pharmaceutical manufacturing context.
Role type
Qualified Person (Quality Management)
Builds
Pharmaceutical batches and quality systems
Domain
Pharmaceutical manufacturing / 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, team leadership, regulatory compliance knowledge
Preferred skills
SAP proficiency, MS Office, cross-functional project collaboration
Technologies
SAP, MS Office
Responsibilities
Oversee batch release approvals, lead and coach a small team, manage quality system processes, act as liaison with contract manufacturers and authorities, participate in audits and inspections
Seniority
Senior, hands-on IC
