JOB DESCRIPTIONS

Quality System Management (QA)

• Develop and improve the Quality Management System (QMS) based on Good Storage Practices (GSP), Good Distribution Practices (GDP), and Good Manufacturing Practices (GMP).
• Monitor environmental conditions and manage quality incidents, including deviations and non-conformances.
• Handle product quality issues, customer complaints, and product recalls. Investigate root causes and propose solutions.
• Conduct incoming goods inspections and make release recommendations.
• Manage equipment calibration, maintenance, and change control for GSP/GDP operations.
• Implement corrective and preventive actions (CAPA) to improve product quality.
• Ensure all necessary product legal documents are up-to-date and organized.
• Prepare for and participate in audits and self-inspections, including internal and external audits, and supplier evaluations.

Pharmacovigilance (PV)

• Manage all PV activities, including monitoring regulatory updates and coordinating with external partners.
• Handle Adverse Drug Reaction (ADR) reports and other safety updates, ensuring timely submission to national authorities and partners.
• Conduct training on PV and ADR reporting for staff and medical representatives.
• Respond to customer inquiries related to PV.
• Participate in investigations of counterfeit drugs.

Compliance & Operations

• Regularly update company policies and procedures, including drafting and revising Standard Operating Procedures (SOPs).
• Ensure compliance with GSP and GDP regulations by preparing and submitting applications and reports to government authorities.
• Organize and supervise drug destruction processes in compliance with regulations.
• Manage departmental assets, including budgeting and procurement.

REQUIREMENTS

• Expertise: Deep knowledge of GSP, GDP, and PV.
• Skills: Strong teamwork, communication, and project management skills.
• Mindset: Highly responsible, detail-oriented, and able to work effectively under pressure.