QA Operation

**QA Operation**

**MAJOR TASKS**
- Perform batch disposition activity within the Cimanggis site, ensuring that the batches have been produced in compliance with the marketing authorization and GMP/GDP requirements.
- Coordinate handling of non-conformity management related to deviations, complaints, out-of-specification issues, and defects from suppliers, including ensuring that investigations are conducted according to the timeline to determine the root cause and define actions.
- Ensure daily activities are performed effectively and efficiently in accordance with current regulations in Quality (GMP, GDP), Safety, food safety, and halal systems.
- Perform QA oversight activities on the shop floor to ensure GMP compliance, food safety, and halal compliance, particularly by coordinating the oversight of the frozen schedule.
- Ensure tracking of the completion of corrective and mitigation actions related to non-conformity issues in the Cimanggis area to maintain high product quality and manufacturing compliance.
- Ensure the implementation of corrective and preventive actions (CAPA) on the shop floor and evaluate their effectiveness to avoid the recurrence of non-conformity issues.
- Evaluate the recurrence, patterns, and trends of non-conformity issues as part of the quality management review and develop the mitigation action plan for continuous improvement.
- Responsible for reviewing and approving the environmental monitoring results and handling the environmental monitoring trend report according to valid procedures.
- Provide quality management review reports on a periodic basis under the QA Operation area.
- Review, approve, and perform the activation/deactivation of the BoM (Bill of Material).
- Coordinate risk management handling within the site, including RA (risk assessment) content review related to quality aspects for non-Operation Areas.
- Support maintaining appropriate precautions for occupational safety and health, as well as security of facilities within Product Quality Assurance activities, and coordinate internal audits.
- Coordinate the evaluation of HIRA (Hazard Identification Risk Assessment) of the working area and ensure the completeness of HIRA training for the team and the implementation of HIRA.

**SKILLS & REQUIREMENTS**
- Pharmacist
- 4+ years of experience in GMP aspects or related areas.
- Deep knowledge of international and local GMP principles for the manufacturing of pharmaceutical products, food supplements, and halal management.
- Knowledge of occupational safety, health, and environmental requirements.
- Understand current GMP as well as other relevant national and international regulations for pharmaceutical products (GMP codes).
- Familiarity with GMP policies and directives through training to enable controlling implementation into local practices.
- Knowledge of international and local GMP principles for the manufacturing of pharmaceutical products, food supplements, and halal management systems.
- Skilled in working and able to work within teams and cross-functional teams.
- Professional English skills.
- Able to handle improvement projects related to the QA area.
- Able to resist any influence that would hamper management decision-making during the absence of the QA Operation Lead.

**Application Period**:

- 23/06/2025

**Reference Code**:

- 848693

**Division**:

- Consumer Health

**Location**:

- Indonesia : West Java : Cimanggis

**Functional Area**:

- Quality

**Position Grade**:

- R.12

**Employment Type**:

- Regular

**Work Time**:

- Standard

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