Manufacturing Compliance Coordinator
Core
Support Manufacturing Compliance Lead in maintaining GMP readiness, investigating quality events, and managing documentation for advanced therapy medicines.
Role type
Manufacturing Compliance Coordinator
Builds
GMP-compliant manufacturing processes and documentation for advanced therapy medicinal products
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP knowledge, batch record management, SOP/protocol revision, deviation investigation, CAPA management, risk identification, audit support
Preferred skills
Biotechnology/Life Sciences background, pharmaceutical environment experience, problem-solving, cross-functional collaboration
Technologies
GMP documentation systems, batch record systems
Responsibilities
Initiate, review and revise batch records, SOPs, protocols, work instructions and other GMP-related documentation; Investigate and manage quality events including deviations, change controls and CAPAs; Support internal and external audits; Drive continuous improvement in processes, planning and training
Seniority
Entry-level to early-career