Business Process Specialist - Logistics Process & Compliance, CVRM
Core
Ensure end-to-end intralogistics processes, material flows, and automated warehousing infrastructure comply with cGMP regulations and Health Authority expectations for a new drug manufacturing facility.
Role type
Senior IC logistics process specialist (cGMP)
Builds
Automated warehousing infrastructure, intralogistics processes, and quality compliance architecture for drug product manufacturing.
Domain
Pharmaceutical manufacturing / Intralogistics / cGMP
Required skills
SAP S/4HANA EWM, Automated Storage and Retrieval Systems (ASRS), Automated Guided Vehicles (AGVs), Autonomous Mobile Robots (AMRs), Warehouse Control Systems (WCS), cGMP regulations, GDP, 21 CFR Part 11, Annex 1 cold-chain, Lean Six Sigma, root-cause analysis, CAPA development, FMEA/risk assessment, data integrity management, change control.
Preferred skills
Greenfield startup operational readiness, vendor acceptance testing, data visualization strategy.
Technologies
SAP S/4HANA, ASRS, AGVs, AMRs, WCS, SAP EWM.
Responsibilities
Define site-level intralogistics processes and material routing plans (PFEP/PFEF), author and review logistics SOPs and validation protocols, support equipment qualification and commissioning for automated systems, serve as SME during FDA/EMA audits, lead root-cause investigations for logistics deviations, monitor intralogistics KPIs and resolve throughput bottlenecks, manage logistics change controls and master data.
Seniority
Senior, hands-on IC