QA Assistant Manager

Qualification

• Bachelor's Degree in Pharmacy, Biomedical Engineering, Industrial Engineering, Chemical Engineering or related fields.
• 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.
• Understanding of ISO 13485:2016 - Medical Device or Good Manufacturing Practices for Medical Devices (CPAKB) and applicable Indonesian medical device regulations.
• Have a knowledge of Risk Management is an advantage.
• Good understanding of Good Documentation Practices (GDP) and Quality Management System documentation requirements.
• Experience in preparing, reviewing, revising, and maintaining Quality Management System documentation, including Quality Manuals, Standard Operating Procedures (SOPs), Work Instructions, and quality records.
• Proficient in English communication, both spoken and written.
• Possess leadership, analytical, attention to detail, and good team coordination skills.
• Strong character : hardworking, adaptable, committed, dedicated, and highly integrity.
• Willing to be placed at Depok – West Java.

Jobdesc

• 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.
• 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.
• Ensuring activities of material and product testing and activities in the laboratory are performed in accordance with principle of Good Laboratory Practices.
• As an Internal Auditor and External Auditor.
• Reviewing and/or approving SOP, WI, and other documents related to Company’s quality management system.
• Ensuring documentat management system in the Company is performed in accordance with procedures
• Reviewing/approving of change control related to quality management system in the Company.
• Preparing quality objective and targets for QA & QC Department and review target proposed by each department.
• Reviewing and/or approving protocol and report of machine, equipment qualification and process validation
• Ensuring every procedures/record can be identified and traceable
• Ensuring any non-conformities are documented and handled in accordance with procedures
• Ensuring of handling of feedback and customer complaint, product recall, returned product handling and product rework are performed in accordance with the procedure
• Approving documents related to internal audit and supplier audit.
• Approving that any corrections, corrective actions and preventive actions taken by each department
• Determining the product disposition status
• Ensuring the handling of material and process status labels are performed properly.
• Approving protocol and report of the product stability study.
• Ensuring the availability of retained product sample
• Reviewing the risk assessment report of each department and ensuring of each risk control are performed by each department.
• Evaluating production results regularly
• Reviewing and approving registration and permission document of the medical devices.