Quality Assurance Manager
Quality Assurance Manager
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
- Quality Management System: Develop, implement, and continuously improve the Quality Assurance system, SOPs, and quality policies in compliance with BPOM, CPOTB/GMP, Halal, and applicable regulations.
- Quality Compliance: Ensure all manufacturing processes, raw materials, packaging materials, and finished products consistently meet quality standards, regulatory requirements, and company specifications.
- Quality Improvement & Risk Management: Lead investigations, Root Cause Analysis (RCA), CAPA implementation, and continuous improvement initiatives to minimize quality risks and improve operational performance.
- Audit & Regulatory Compliance: 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.
- Cross-Functional Collaboration: Partner with Production, R&D, Engineering, Supply Chain, and Regulatory Affairs to ensure product quality throughout the product lifecycle, including new product development.
- Quality Documentation & Reporting: Oversee quality documentation, deviation management, change control, product release, and quality reporting to support business and regulatory requirements.
- Team Leadership: Lead, coach, and develop the Quality Assurance team while fostering a strong culture of quality, compliance, and continuous improvement across the organization.
Qualifications
- 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.
- Strong knowledge of CPOTB/GMP, BPOM regulations, Halal Assurance System, ISO 9001, ISO 22000, and Quality Management Systems.
- Experienced in internal/external audits, CAPA, Root Cause Analysis (RCA), FMEA, SPC, risk management, and quality improvement initiatives.
- Proficient in Microsoft Office and quality management systems.
- Strong leadership, analytical thinking, communication, problem-solving, and stakeholder management skills.
- Willing to be based at Yogyakarta.