QC Supervisor

PT Adventa Biotech International; Kaliwungu; On-site; IDR 133,920,000 - 223,200,000; Full time

Job summary

PT Adventa Biotech International seeks a QC coordinator to lead inspection activities and ensure compliant sampling, analysis and documentation across raw materials to finished products.

You will prepare HULS reports, manage instrument calibration, and supervise lab personnel while maintaining safety and quality standards in a GMP environment.

Qualifications

• Minimum bachelor's degree in Chemistry, Pharmacy, Science, or related field.
• At least 5 years in Quality Control with 2 years in a supervisor role.
• Experience in pharmaceutical, medical device or sterile products industry.
• Familiarity with ISO 13485 and CPAKB is a plus.
• Strong communication, analytical and team coordination abilities.

Responsibilities

• Coordinate activities of analysts and IPCs in health facilities during inspections of raw materials, packaging materials, intermediates, bulk and finished products.
• Arrange scheduling and prioritization of inspections for materials.
• Ensure sampling and analysis procedures are followed with proper documentation.
• Prepare HULS reports and investigations for materials and finished products, and submit to Quality Manager.
• Prepare summary reports for materials and submit to Quality Manager.
• Ensure cleaning of medical equipment and lab areas and proper handling of lab waste.
• Maintain and care for instruments to keep them in good condition; follow up on damages.
• Ensure timely calibration of equipment and instruments.
• Maintain stocks of reagents and other materials in the QC laboratory.
• Coordinate handling of residual samples in the QC laboratory.
• Create work instructions for machines and systems in the medical equipment QC area and implement good documentation.
• With the Quality Manager, conduct routine checks for BPR/PR and supervise work safety.

Skills

Presentation skills

Analytical skills

Team coordination

Detail oriented

Education

Bachelor's degree in Chemistry, Pharmacy, Science

Tools

Instrument calibration

Machine qualification

Validation processes

Microsoft Office

Statistical analysis

Job description

Coordinate the activities of analysts and IPCs in health facilities in conducting inspections of raw materials, packaging materials, intermediate products, bulk products, and finished products.

Arrange the scheduling and prioritization of inspections of raw materials, packaging materials, intermediate products, bulk products, and finished products.

Ensure that sampling and analysis procedures for raw materials, packaging materials, intermediate products, bulk products, and finished products are carried out correctly, along with the relevant documentation.

Prepare HULS (Out-of-Specification Test Results) reports along with investigations on raw materials, packaging materials, intermediate products, and finished products, and submit these reports to the Quality manager.

Prepare summary reports on raw materials, packaging materials, intermediate products, bulk products, and finished products, and submit them to the Quality Manager.

Ensure that the cleaning of medical equipment and laboratory areas, as well as the handling of medical laboratory waste, is carried out correctly.

Maintain and care for instruments and equipment in the medical laboratory to ensure they are always in good condition. Immediately follow up if any damage to equipment or instruments is detected.

Ensure that the calibration of equipment and instruments is carried out on time.

Maintain stocks of reagents and other materials in the QC laboratory.

Coordinate the handling of residual samples in the QC laboratory.

Create work instructions for machines and systems in the medical equipment QC area, including conducting socialization and implementing a good documentation system in the QC lab.

Together with the Quality Manager, conduct routine checks for BPR/PR.

Together with the Quality Manager, be responsible for the implementation of work safety in the Medical Equipment Laboratory area.

Job Qualifications :

Minimum bachelor's degree in Chemistry, Pharmacy, Science, or other relevant disciplines.

Minimum 5 years of experience in the Quality Control Department with 2 years of supervisor experience.

Experienced in the pharmaceutical, medical device, or sterile products industry.

Familiarity with ISO 13485 and CPAKB requirements is a plus.

Good presentation skills, analytical skills, and team coordination skills.

Honest, decisive, detail oriented, and able to work under pressure.

Possess skills in instrument calibration, machine qualification, and validation processes.

Minimum proficiency in Microsoft Office programs and statistical analysis.

PT Adventa Biotech International is a wholly owned subsidiary of Adventa Berhad, with a long history of serving healthcare institutions across the country, supplying single-use dialysis products, medical equipment, and medical devices since 1981.

Our commitment is to be a manufacturer of medical devices meeting international standards by providing excellent service to both local and international customers through high-quality products. We place great emphasis on the cleanliness and quality of our production in accordance with ISO 13485:2016 standards and the principles of Good Manufacturing Practice for Medical Devices (GMP).

PT Adventa Biotech International is a wholly owned subsidiary of Adventa Berhad, with a long history of serving healthcare institutions across the country, supplying single-use dialysis products, medical equipment, and medical devices since 1981.

Our commitment is to be a manufacturer of medical devices meeting international standards by providing excellent service to both local and international customers through high-quality products. We place great emphasis on the cleanliness and quality of our production in accordance with ISO 13485:2016 standards and the principles of Good Manufacturing Practice for Medical Devices (GMP).