Job Openings - Mersifarma

Quality Assurance (QA) Manager

Ensure the effective implementation and management of all Quality Assurance activities in compliance with CPOB standards
Ensure all manufacturing and quality processes comply with GMP/CPOB standards
Oversee quality systems, including Deviation management, CAPA (Corrective and Preventive Actions), Change Control & Risk Management
Lead internal audits and manage external audits (regulatory authorities, clients, certification bodies)
Review and approve : Batch records, SOPs, Validation documents & Product specifications
Oversee validation and qualification activities (IQ/OQ/PQ)
Ensure proper documentation and data integrity in all quality-related activities
Collaborate with cross-functional teams (Production, QC, R&D, Regulatory Affairs)
Drive continuous improvement initiatives within the quality system
Conduct training programs related to QA and regulatory compliance
Responsible for product release (batch release) in accordance with authority and regulations

Bachelor’s Degree in Pharmacy with Registered Pharmacist (Apothecary) license is mandatory; Master’s Degree is an advantage
Minimum 5–8 years of experience in Quality Assurance within the pharmaceutical industry
At least 2–3 years of managerial experience
Strong knowledge of GMP (Good Manufacturing Practices), Quality Management System, Validation (process, cleaning, method, etc.), Internal & external audit processes
Certification in QA/GMP is preferred
Strong understanding of regulatory requirements (BPOM, WHO, PIC/S, etc.)
Excellent analytical thinking, problem-solving, and attention to detail
Strong leadership and communication skills