Quality Engineer
Core
Ensuring compliant manufacturing and product release operations for plant-based ingredients and pharmaceutical excipients at a regulated manufacturing site.
Role type
Quality Engineer (Regulated Manufacturing)
Builds
Compliant batches of plant-based ingredients and pharmaceutical excipients for global markets
Domain
Food/feed ingredients and pharmaceutical excipients manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance (ICH Q7, IPEC-PQG), deviation management, CAPA, risk assessment, change control, batch record review, audit participation, QMS maintenance
Preferred skills
SAP/ERP systems, electronic QMS tools, HACCP knowledge
Technologies
SAP, electronic QMS tools
Responsibilities
Ensure compliance with ICH Q7, IPEC-PQG GMP Guidelines, and FSSC 22000; Act as Quality representative for shop-floor manufacturing; Support batch record review and product release; Provide quality oversight of manufacturing operations including deviation handling; Review and approve manufacturing documentation; Lead or support investigations related to deviations and complaints; Participate in internal, customer, and regulatory audits; Support maintenance and improvement of the Quality Management System (QMS)
Seniority
Mid-Senior, hands-on IC
