Mitarbeiter Prozessdokumentation(w/m/d)
Core
Ensuring timely finalization of batch and laboratory documentation in compliance with GMP and regulatory requirements, including data entry, verification, and deviation reporting.
Role type
Process Documentation Specialist (Pharmaceutical Manufacturing)
Builds
Batch documentation, Certificates of Analysis (DoC), and validation documents for pharmaceutical production
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP knowledge, SAP/MES data entry, batch documentation, deviation reporting, training planning and execution, MS Office proficiency
Preferred skills
Quality Management, Lean Management methods
Responsibilities
Compile batch documentation before and after production; Enter IPK and EPK results and verify specification compliance; Initiate deviation reports and create Certificates of Analysis (DoC); Participate in creating predefined documents (MBR, Manufacturing Specification, SOP, validation documents); Plan and conduct employee training; Support projects
Seniority
Entry to Mid-level, hands-on IC
