Quality Assurance Operation

1 week ago


Depok, Indonesia Bayer Full time

**QA Operation**

**PURPOSE**

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.

**MAJOR TASKS**
- 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.

**WHO YOU ARE**
- 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.

**Application Period**:

- 12/30/2024

**Reference Code**:

- 836545

**Division**:

- Consumer Health

**Location**:

- Indonesia : West Java : Cimanggis

**Functional Area**:

- Quality

**Position Grade**:

- R.11

**Employment Type**:

- Regular

**Work Time**:

- 3 shift models

**Contact Us**
- Address
- Telephone
- E-Mail



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