Job Description
Responsible for developing and managing the overall quality strategy, systems, and compliance processes in accordance with WHO/EU GMP standards, ensuring the highest standards of product quality and regulatory compliance for the manufacturing site.
• Develop quality policies and a comprehensive Quality Management System (QMS) for the manufacturing site.
• Operate and evaluate the effectiveness of the overall Quality System.
• Improve processes and ensure full compliance with WHO/EU GMP.
• Guide and develop a quality team that is prepared for regulatory inspections.
• Act as a Qualified Person (QP) for product release or delegate in writing when absent.
• Review and approve Quality System documents as authorized by the Board of Directors.
• Monitor contract manufacturing activities (if applicable).• Conduct Annual Product Quality Reviews and assess the effectiveness of the QMS.
• Supervise internal audit implementation and ensure timely execution.
• Represent the company in customer audits and inspections by health authorities.
• Ensure timely corrective and preventive actions (CAPAs) following audits and propose preventive and continuous improvement measures.
• Oversee adherence to the validation master plan and timely investigation resolution.
• Monitor maintenance and repairs of equipment and facilities per GMP requirements.
• Manage CAPAs arising from self-inspections and external audits to ensure deadlines are met.
• Handle Change Control processes and ensure on-time completion.
• Manage Deviations and ensure effective corrective actions are implemented.
• Supervise and ensure proper handling of market complaints, deviations, OOS, product recalls, and field alerts.
• Make final decisions on the use or rejection of raw materials, packaging, and finished products; consult the Board of Directors for major decisions.
• Audit suppliers of raw materials and primary packaging to ensure GMP compliance.
• Review and approve Quality Agreements with suppliers and partners.
• Lead process improvement initiatives, introduce new procedures, and oversee staff training.
• Provide regular and ad hoc reports to senior management.
• Ensure compliance with both local and international regulations.
• Collaborate with Medical Affairs to handle adverse reaction complaints.
• Coordinate product recalls when required.
• Ensure all necessary licenses are maintained and valid.
• Contribute investment plans related to the Quality Division.
• Ensure compliance with EHS (Environment, Health & Safety) policies, procedures, and international standards.
• Directly manage the QA and QC departments.
• Perform other tasks assigned by the Board of Directors.
Job Requirements
• Bachelor’s degree or higher in Pharmacy or related field.
• Having practical license
• At least 10 years of experience in pharmaceutical quality management, with a minimum of 5 years in a senior leadership role.
• In-depth knowledge of WHO/EU GMP, ICH guidelines, and international regulatory requirements.
• Strong leadership, analytical thinking, and problem-solving skills.
• Excellent communication and team management abilities.
• Experience in regulatory inspections and audits (e.g., WHO, EMA, FDA) is preferred.
• Proficiency in Microsoft Office