Quality Assurance Supervisor

Job Descriptions:

1. Reviewing and monitoring deviation reports and their corresponding logsheets, including those for qualification, validation, and calibration.

2. Managing internal CAPAs (Corrective and Preventive Actions) and coordinating the creation of CAPAs for external audits.

3. Reviewing and monitoring change control submissions, including those related to qualification and validation.

4. Reviewing and monitoring risk analysis submissions, including those related to qualification and validation.

5. Coordinating internal and external investigations by established procedures.

6. Coordinating product recalls and the handling of product quality complaints.

7. Coordinating the destruction of rejected raw materials, packaging materials, and finished products.

8. Conducting and monitoring internal and external audit programs in conjunction with the audit team.

9. Coordinating and ensuring the implementation of personnel training for all departments.

10. Ensuring that batch processing and packaging records are reviewed by established procedures.

11. Conducting periodic Product Quality Reviews (PQRs).

12. Coordinating the validation, qualification, and calibration processes with the relevant teams.

13. Monitoring the management of quality system documents, including review schedules and the finalization of approvals.

14. Providing input to the QA Manager for decision-making regarding quality, rewards, and sanctions.

15. Reporting on the execution of all duties and responsibilities to the Quality Assurance Manager.

Job Qualifications:

1. Minimum of a Diploma (D3) in Mathematics and Natural Sciences/Engineering or equivalent, fresh graduate, or with at least one year of experience in the pharmaceutical/medical device industry in a similar field.

2. Knowledge of occupational safety and health standards.

3. Knowledge of good labor management and regulations.

4. Fluent in English.

5. Knowledge and experience in Good Manufacturing Practices for Medical Devices (GMP), ISO 13485, and cGMP.

6. In-depth understanding of the quality assurance for medical devices or pharmaceuticals.

Information :

• Company : PT Adventa Biotech International
• Position : Quality Assurance Supervisor
• Location : Kendal
• Country : ID