QA Assistant Manager

Qualification :

1.       Bachelor's Degree in Pharmacy, Biomedical Engineering, Industrial Engineering, Chemical Engineering or related fields.

2.       Minimum 5 years of experience in Quality Assurance within the medical device, pharmaceutical, or other regulated manufacturing industries, including at least 3 years in a supervisory or assistant managerial role.

3.       Understanding of ISO 13485:2016 - Medical Device or Good Manufacturing Practices for Medical Devices (CPAKB) and applicable Indonesian medical device regulations.

4.       Have a knowledge of Risk Management is an advantage.

5.       Good understanding of Good Documentation Practices (GDP) and Quality Management System documentation requirements.

6.       Experience in preparing, reviewing, revising, and maintaining Quality Management System documentation, including Quality Manuals, Standard Operating Procedures (SOPs), Work Instructions, and quality records.

7.       Proficient in English communication, both spoken and written.

8.       Possess leadership, analytical, attention to detail, and good team coordination skills.

9.       Strong character : hardworking, adaptable, committed, dedicated, and highly integrity.

10.  Willing to be placed at Depok – West Java.

Jobdesc :

1.       Ensuring Good Manufacturing Practices and Quality Management System based on ISO 13485:2016 and Good Manufacturing Practices for Medical Devices (GMPMD) requirements are performed properly and correctly.

2.       Manage overall QA & QC activities, create the system and procedures, and ensure that all of processes and products are meet the requirements or specified standard.

3.       Ensuring activities of material and product testing and activities in the laboratory are performed in accordance with principle of Good Laboratory Practices.

4.       As an Internal Auditor and External Auditor.

5.       Reviewing and/or approving SOP, WI, and other documents related to Company’s quality management system.

6.       Ensuring documentat management system in the Company is performed in accordance with procedures

7.       Reviewing/approving of change control related to quality management system in the Company.

8.       Preparing quality objective and targets for QA & QC Department and review target proposed by each department.

9.       Reviewing and/or approving protocol and report of machine, equipment qualification and process validation

10.  Ensuring every procedures/record can be identified and traceable

11.  Ensuring any non-conformities are documented and handled in accordance with procedures

12.  Ensuring of handling of feedback and customer complaint, product recall, returned product handling and product rework are performed in accordance with the procedure

13.  Approving documents related to internal audit and supplier audit.

14.  Approving that any corrections, corrective actions and preventive actions taken by each department

15.  Determining the product disposition status

16.  Ensuring the handling of material and process status labels are performed properly.

17.  Approving protocol and report of the product stability study.

18.  Ensuring the availability of retained product sample

19.  Reviewing the risk assessment report of each department and ensuring of each risk control are performed by each department.

20.  Evaluating production results regularly

21.  Reviewing and approving registration and permission document of the medical devices.