Quality Management System(F/M/X)
Detail posisi
Solvay is focused on chemistry and values the collaboration of diverse minds to improve lives while preserving the planet. The Quality Management System Operator will contribute to the production department, ensuring compliance and quality in chemistry products.
Kewajiban
• Implement GMP compliance across the plant to meet regulatory requirements for business sustainability.
• Implement QMS system compliance for adherence of process and product compliance as per regulatory norm.
• Preparation and review of APQR.
• Ensure smooth operation of QMS activity (all types of qualifications and validations, self-inspection, change control, deviations, CAPA, SOP, customer complaints, customer questionnaires and training within timelines).
• Preparation and scheduling validation quality management system plan, preparation and maintenance of system management facility.
• Register for new additional products, ISO, FDA approval, free sale certificate.
• Liaison with various regulatory and accrediting bodies for obtaining the same.
• Handle customer, regulatory and internal audit (Self inspection at the plant, GQA audit). This includes planning, execution, implementation of CAPA and closure of the same.
• Ensure and drive the document (SOPs, Formats, etc.) control at the plant. This involves the system for issuance, traceability, up-dation, reconciliation, retrieval, archival and review the same.
• Preparation and submission of weekly report (QMS related).
Kualifikasi
• Bachelor degree in Chemical, Industrial, Food technology and Food Science or relevant.
• More than 5 years of experience in a QA role with relevant experience in Quality Manufacturing chemical, Food and registration products for FDA.
• Strong in quality management system.
• English is communicable.
• Proficiency in ISO 9001 / HACCP.
• Knowledge in GMP’s, inspecting/auditing guidelines.