Quality Assurance Operation

Bayer (Indonesia) (Cimanggis, West Java, Indonesia)

West Java, Indonesia

Bayer is a global enterprise with core competencies in the life science fields of healthcare and nutrition. We design our products and services to serve the most essential human needs of health and nutrition. At the same time, we strive to address some of the world’s biggest challenges presented by a growing and aging global population. At Bayer, we’re committed to driving sustainable development and generate a positive impact with our businesses. Through the power of science, we’re pioneering new possibilities that advance life for all of us. That means reimagining how we care for ourselves and one another by empowering everyday health, improving approaches to patient care, and finding better ways to nourish our communities around the world.

About this position

Perform QA Oversight and Product Quality Assurance activity within PT Bayer Indonesia from incoming material in the warehouse until Finish Good dispatching into customer for value stream A/B cluster including issue management, and risk assessment handling.

Responsibilities

• Coordinate the management of non-conformities, including deviations, complaints, out-of-specification results, and supplier defects, ensuring timely investigations are conducted to identify root causes and define corrective actions.
• Oversee manufacturing processes, including in-process controls during the production of Cluster A/B and non-Operational areas, ensuring product quality and compliance with BAS GMP alarms, critical process control monitoring, and evaluations.
• Ensure daily activities are conducted efficiently and effectively in compliance with current regulations for Quality (GMP, GDP), Safety, Food Safety, and Halal standards.
• Perform QA oversight on the shop floor to ensure compliance with GMP, food safety, and Halal standards.
• Track the completion of corrective and mitigation actions related to non-conformities in the Cimanggis area, maintaining high product quality and manufacturing compliance.
• Ensure the implementation of corrective and preventive actions (CAPA) on the shop floor, evaluating their effectiveness to prevent the recurrence of non-conformities.
• Analyze recurrence patterns and trends of non-conformities as part of quality management reviews and develop mitigation plans for continuous improvement.
• Review environmental monitoring results and prepare environmental monitoring trend reports according to applicable procedures.
• Provide periodic quality management review reports within the QA Operational area.
• Support the implementation of occupational safety, health precautions, and facility security within QA Oversight and Product Quality Assurance activities.
• Coordinate and evaluate HIRA (Hazard Identification and Risk Assessment) for the workplace, ensure team completion of HIRA training, and oversee the implementation of HIRA procedures.

Requirements

• Licensed pharmacist or minimum bachelor’s degree in any field.
• At least 2 years of experience in GMP, preferably in manufacturing (production/packaging).
• Willing to work in a 3-shift schedule.
• Strong knowledge of international and local GMP principles for pharmaceutical products and food supplements.
• Proficient in handling and mitigating issues such as deviations, OOS, complaints, and non-conformities.
• Familiarity with occupational safety, health, and environmental requirements.
• Comprehensive understanding of current GMP and related national and international pharmaceutical regulations.
• Effective teamwork skills and ability to collaborate within teams.
• Proficient in professional English communication.
• Ability to remain impartial and resist undue influence in work-related matters.