Job Summary
Responsible for leading the Quality Assurance function, ensuring compliance with CPOTB/GMP, BPOM, Halal, and other applicable quality standards. This role oversees quality systems, regulatory compliance, internal and external audits, continuous improvement initiatives, and cross-functional quality management to ensure consistent product quality and manufacturing excellence.
Key Responsibilities
Develop, implement, and continuously improve the Quality Assurance system, SOPs, and quality policies in compliance with BPOM, CPOTB/GMP, Halal, and applicable regulations.
Ensure all manufacturing processes, raw materials, packaging materials, and finished products consistently meet quality standards, regulatory requirements, and company specifications.
Lead investigations, Root Cause Analysis (RCA), CAPA implementation, and continuous improvement initiatives to minimize quality risks and improve operational performance.
Lead internal and external audits, manage regulatory inspections, and ensure timely closure of audit findings while maintaining compliance with BPOM, Halal, ISO, and GMP requirements.
Partner with Production, R&D, Engineering, Supply Chain, and Regulatory Affairs to ensure product quality throughout the product lifecycle, including new product development.
Oversee quality documentation, deviation management, change control, product release, and quality reporting to support business and regulatory requirements.
Lead, coach, and develop the Quality Assurance team while fostering a strong culture of quality, compliance, and continuous improvement across the organization.
Bachelor's Degree in Pharmacy, Chemistry, Food Technology, Biology, Chemical Engineering, or a related field.
Minimum 5-7 years of experience in Quality Assurance, with at least 3 years in a managerial role within the Pharmaceutical, Herbal, Food & Beverage, Cosmetics, or FMCG manufacturing industry.
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