Mitarbeiter Batch Release Unit (m/w/d) - befristet bis einschließlich März 2026
Core
Quality assurance specialist responsible for batch release documentation, Product Quality Reviews (PQRs), and ICH Q3D elemental impurity assessments for pharmaceutical, cosmetic, and nutritional products.
Role type
Quality Assurance Specialist (Batch Release)
Builds
GMP-compliant batch records, quality assessments, and regulatory documentation for pharmaceutical and cosmetic products.
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP knowledge, ICH Q3D expertise, batch documentation management, PQR creation, regulatory compliance, data analysis, supplier information evaluation
Preferred skills
Additional ICH/GMP guidelines knowledge, customer inquiry handling, quality assessment experience
Technologies
GMP systems, ICH guidelines, quality management software
Responsibilities
Create and review batch records for release, conduct Product Quality Reviews (PQRs) for customer products, perform ICH Q3D elemental impurity assessments, support Qualified Person (QP) in documentation review, ensure timely completion of quality tasks and deadlines, participate in internal audits and regulatory inquiries
Seniority
Mid-level, hands-on specialist