Expert Technical Operations (LdH) (m/w/d)
Core
Responsible for leading manufacturing operations and ensuring pharmaceutical quality of active pharmaceutical ingredients and drugs in the assigned area.
Role type
Senior manufacturing operations leader (GMP)
Builds
Pharmaceutical active ingredients and drugs
Domain
Life sciences / Pharma manufacturing
Required skills
GMP compliance, German pharmaceutical law (AMG, AMWHV), process optimization, root cause analysis, validation management, project leadership, regulatory documentation
Preferred skills
Technical planning, risk management, personnel management, equipment improvement coordination
Technologies
GMP documentation systems, Master Batch Records, Batch Records
Responsibilities
Ensure GMP-conformant manufacturing processes according to German and European law; Optimize processes and minimize losses; Coordinate implementation of measures from disturbances and deviations; Capture and escalate technical and procedural problems; Participate in creating and improving Master Batch Records; Approve manufacturing instructions and review Batch Records; Ensure all deviations are documented and evaluated; Ensure validation of manufacturing procedures; Act as project leader according to GenTSV § 14
