Quality Management Expert(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 Expert will play a crucial role in ensuring compliance and quality within the production department.
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.