Job Openings - Mersifarma

Asst. Manager QA

Plan, organize, and oversee Quality Assurance activities to ensure compliance with applicable GMP standards and company quality systems
Monitor and evaluate quality control processes across raw materials, production, and finished products to ensure consistency and compliance
Lead and supervise QA team members in daily operations, including task delegation, performance monitoring, and development
Ensure GMP compliance and manage documentation related to internal and external audits, including CAPA implementation and effectiveness monitoring
Review and approve quality documents, including SOPs, reports, deviations, change controls, and validation protocols
Lead investigations on product deviations, out-of-specification (OOS) results, and complaints, and ensure timely corrective and preventive actions
Coordinate with cross-functional teams (Production, QC, R&D) to resolve quality-related issues and improve processes
Support regulatory inspections and ensure readiness for audits by external parties (e.g., BPOM or other authorities)
Drive continuous improvement initiatives related to quality systems and compliance

Male/Female
Maximum 45 years old
Minimum Professional Degree in Pharmacy (Apoteker)
3–5 years of experience in the same field, preferably in the pharmaceutical industry (experience in sterile products is an advantage)
Good command of English
Strong analytical thinking, leadership, communication, problem-solving, change control, and investigation skills
Strong understanding of Quality Management Systems, including quality documentation, Corrective and Preventive Actions (CAPA), risk management, validation, and internal & external audits
Knowledge of GMP, precursor chemicals, as well as validation, qualification, and calibration processes
Willing to be placed in Sukabumi Plant, West Java