Fachverantwortliche:r GMP-Analytik (m/w/d)
Core
Leading the setup of a new GMP analytical department, establishing processes, standards, and quality systems while ensuring compliant sample processing and analysis.
Role type
Senior GMP Analytical Team Lead (setup phase)
Builds
New GMP analytical department, processes, and quality standards
Domain
Pharmaceutical/Chemical industry, GMP-regulated environment
Required skills
GMP compliance, method validation, SOP development, resource planning, OOS/OOT investigation, audit support, analytical measurement, result review
Preferred skills
Experience in GMP-regulated environment or pharma industry, automation systems, robotics
Technologies
Analytical instruments, automation systems, robots
Responsibilities
Designing and implementing new analytical methods, conducting method validations, planning resources and capacity, reviewing and releasing analysis results, supporting OOS/OOT investigations, preparing for customer audits and regulatory inspections
Seniority
Senior, hands-on IC with leadership potential