Establish, implement, and maintain the Pharmaceutical Quality System (PQS) in compliance with WHO-GMP and current pharmaceutical regulations.
Develop, review, approve, and control quality documentation, including SOPs, master batch records, specifications, protocols, and quality-related records.
Manage Change Control processes to ensure all changes related to processes, equipment, materials, utilities, or personnel are properly evaluated and approved without impacting product quality.
Lead deviation investigations, perform Root Cause Analysis (RCA), and implement Corrective and Preventive Actions (CAPA).
Conduct Annual Product Quality Reviews (PQR/APR) to monitor process consistency, product quality trends, and continuous improvement opportunities.
Validation & Qualification
Develop and maintain the Validation Master Plan (VMP).
Oversee and approve qualification and validation activities, including:
Equipment Qualification (IQ/OQ/PQ)
Process Validation
Cleaning Validation
Utility System Validation (HVAC, RO/WFI water systems, compressed air systems)
Inspection & Compliance
Organize and conduct periodic self-inspections to ensure full compliance with WHO-GMP standards across all departments.
Lead supplier qualification and audit activities for raw materials, packaging materials, and technical service providers.
Act as the primary contact person during inspections and audits conducted by the Drug Administration of Vietnam (DAV) and other regulatory authorities.
Production & Batch Release Control
Supervise in-process quality control (IPQC) activities to ensure manufacturing operations comply with approved SOPs and GMP requirements.
Review manufacturing and quality control batch records before submission to the Qualified Person (QP) for batch release approval.
Training & Development
Develop and deliver GMP, SOP, quality compliance, and safety training programs for factory employees.
Promote quality awareness and continuous improvement culture throughout the organization.
QUALIFICATIONS
Bachelor’s degree or above in Pharmacy (Licensed Pharmacist preferred).
Minimum 5 years of experience in Quality Assurance within a pharmaceutical manufacturing environment.
Must be officially registered as the Quality Assurance responsible person in the factory’s GMP license.
Strong knowledge of WHO-GMP, GLP, GSP, and current pharmaceutical regulations.
Hands-on experience in deviation handling, CAPA, validation, self-inspection, and regulatory audits.
Strong leadership, problem-solving, analytical thinking, and time management skills.
Good communication and stakeholder management skills.
