PIC/GMP QA Pharmacist – Compliance Leader & Inspections

PT Meiji Indonesian Pharmaceutical Industries; Jawa Timur; On-site; IDR 120,000,000 - 180,000,000; Full time

Job summary

PT Meiji Indonesian Pharmaceutical Industries is seeking a QA Pharmacist for PIC compliance to enforce GMP standards and align the Pharmaceutical Quality System with PIC/S guidelines. The role emphasizes leading CAPA, audits, and regulatory readiness to safeguard patient safety and licensure.

The successful candidate will oversee QA activities, document control workflows, and act as an expert during regulatory inspections, ensuring quality across equipment qualification, analytical methods, and

Qualifications

• Experience in pharmaceutical QA and GMP environments (implied by role)
• Familiarity with PIC/S guidelines and PQS structure
• Ability to lead CAPA, audits, and regulatory readiness

Responsibilities

• Design, implement, and maintain a proactive Quality Management System
• Lead risk-based evaluations (FMEA) for process changes, deviations, and validations
• Enforce ALCOA Plus across logs, BMRs, and electronic systems
• Lead investigations into deviations, OOS results, and line failures using 5-Whys/Fishbone
• Author and verify CAPAs to prevent recurrence
• Schedule, execute, and document internal audits following PIC/S site-master file guidelines
• Support regulatory inspections with document control and evidence retrieval
• Review and approve IQ/OQ/PQ protocols and other analytical methods

Skills

GMP compliance

PIC/S standards

Quality Management

FMEA

ALCOA Plus

CAPA

Audits

Regulatory inspections

Documentation control

IQ/OQ/PQ

Job description

PT Meiji Indonesian Pharmaceutical Industries is seeking a QA Pharmacist for PIC compliance to enforce GMP standards and align the Pharmaceutical Quality System with PIC/S guidelines. The role emphasizes leading CAPA, audits, and regulatory readiness to safeguard patient safety and licensure.

The successful candidate will oversee QA activities, document control workflows, and act as an expert during regulatory inspections, ensuring quality across equipment qualification, analytical methods, and