Deskripsi pekerjaan QA & Regulatory Manager PT Orson Indonesia
JOB DESCRIPTION
Quality Assurance & QMS Management
- Lead the implementation and maintenance of the Quality Management System (QMS) across manufacturing operations in accordance with GMP/CPKB, ISO 9001, BPOM requirements, and applicable standards.
- Ensure quality procedures, SOPs, specifications, and quality documentation are properly implemented and maintained.
Regulatory Compliance & Product Registration
- Oversee regulatory compliance for products, raw materials, packaging materials, and manufacturing activities.
- Manage product registration, notification, certification, regulatory submissions, and communication with BPOM and other relevant authorities.
CAPA, Deviation & Change Control
- Review and oversee deviation, non-conformity, complaint, CAPA, and Change Control processes.
- Ensure root cause analysis and corrective/preventive actions are effectively implemented to prevent recurrence.
Product Quality & Compliance Review
- Monitor product quality and compliance from raw materials through production and finished goods release.
- Review quality trends, specifications, test results, complaints, and other quality indicators to identify potential risks and improvement opportunities.
Cross-Functional Quality Coordination
- Coordinate with Production, QC, R&D/Formulation, Regulatory, Warehouse, Purchasing, and other departments to resolve quality and regulatory issues.
- Provide quality and regulatory guidance for new products, formulation changes, packaging changes, and process improvements.
Quality & Regulatory Reporting
- Establish and monitor quality and regulatory KPIs, prepare management reports, and provide recommendations for continuous improvement.
- Ensure regulatory licenses, certificates, product documentation, and quality records remain valid, complete, and properly controlled.
Team Management & Quality Culture
- Supervise and develop QA and Regulatory personnel to ensure effective execution of quality and regulatory activities.
- Promote quality awareness, GMP/CPKB compliance, and continuous improvement throughout the organization.
JOB QUALIFICATIONS:
- Education: Bachelor's Degree (S1) in Pharmacy, Chemistry, Food Science, Biology, Chemical Engineering, or a related field; professional pharmacist qualification is an advantage.
- Experience: Minimum 5 years of experience in QA, Quality Management, Regulatory Affairs, or related functions, with at least 2 years in a managerial/supervisory position, preferably in cosmetics, personal care, FMCG, pharmaceutical, chemical, or manufacturing industries.
- Quality Management: Strong knowledge of GMP/CPKB, ISO 9001, Quality Management Systems, QA processes, internal audits, quality documentation, and continuous improvement.
- Regulatory Knowledge: Strong understanding of BPOM regulations, product registration/notification, product compliance, labeling, claims, raw material requirements, and applicable regulatory standards.
- Quality Problem Solving: Experienced in handling CAPA, deviation, non-conformity, Change Control, customer complaints, root cause analysis, and quality risk management.
- Audit & Compliance: Experienced in managing internal, external, customer, certification, and regulatory audits, including preparation, finding responses, CAPA, and follow-up activities.
- Leadership & Cross-Functional Management: Strong leadership, analytical, decision-making, communication, and stakeholder-management skills with the ability to coordinate effectively across Production, QC, R&D, Regulatory, Warehouse, and other functions.
- Systems & Reporting: Proficient in Microsoft Office and quality management/documentation systems, with strong capability in analyzing quality data, preparing management reports, and monitoring quality and regulatory KPIs.