Quality Assurance Pharmacist

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

A Quality Assurance (QA) Pharmacist for PIC Compliance plays a critical role in enforcing Good Manufacturing Practice (GMP) standards dictated by the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

A PIC-focused QA Pharmacist ensures that the entire Pharmaceutical Quality System (PQS) aligns perfectly with rigorous, harmonized global inspection criteria to safeguard patient safety and preserve institutional licensure.

Main Key responsibilities

Design, implement, and maintain a proactive Quality Management System that prioritizes product quality and patient safety

Lead scientific, risk based matrix evaluations (such as FMEA) for all manufacturing process changes, deviations, and validations

Enforce strict adherence to ALCOA Plus principles across all physical logbooks, batch manufacturing records (BMRs), and electronic management systems

Lead investigations into system deviations, out-of-specification (OOS) results, and technical line failures using 5-Whys or Fishbone methodologies

Author, monitor, and verify Corrective and Preventive Actions (CAPAs) to guarantee that immediate process issues are resolved and systemic recurrences are blocked

Schedule, execute, and document formal internal audits built specifically around the PIC/S site-master file guidelines

Serve as a key subject matter expert during official regulatory inspections, managing document control workflows and real-time evidence retrieval

Review and approve protocols spanning equipment qualification (IQ/OQ/PQ), analytical methods, and complex automated processing systems

Your application will include the following questions:

• Berapa tahun pengalaman kerjamu sebagai Apoteker QA?
• Berapa tahun pengalaman kerjamu di Industri Farmasi?
• Bagaimana kamu menilai kemampuan bahasa Inggrismu?

As a pioneer of quality antibiotics since its foundation in 1974, PT. Meiji Indonesia as a subsidiary of Meiji Seika Pharma Co.,Ltd. Japan, is currently one of the few players in this sector delivering highest production quality standards in Indonesia.

PT. Meiji Indonesia produces prescription drugs, OTC drugs, and Veterinary Drugs that have been successful in both local and international markets. We continue to innovate by combining years of expertise with the support of today's technology. Our products are made from the finest raw materials, processed in facilities of international standards.

As a pioneer of quality antibiotics since its foundation in 1974, PT. Meiji Indonesia as a subsidiary of Meiji Seika Pharma Co.,Ltd. Japan, is currently one of the few players in this sector delivering highest production quality standards in Indonesia.

PT. Meiji Indonesia produces prescription drugs, OTC drugs, and Veterinary Drugs that have been successful in both local and international markets. We continue to innovate by combining years of expertise with the support of today's technology. Our products are made from the finest raw materials, processed in facilities of international standards.