Assistant Manager - Quality Management

1. Assist QM manger to ensure establishment and maintenance of the quality management system to meet WHO GMP, ISO as well as other regulatory and company requirement
• Creating, reviewing & revising QM documents. Properly apply production and operation controls to meet GMP, ISO ad related regulatory requirements.
• Establish and lead the annual audit program (internal, external and division...) include unplanned audit and inspection.
• Finalize QM statement at B.TraQS and SAP system.
• Coordinate and follow up the CAPA, Customer Complaints, Audits, Change Control, Risk Management with relevant stakeholders to ensure all matters are solved properly and in accordance with requirements, include verify improvement actions and evidence.
• Act as local medical device and nutrient safety officer, include execute properly relevant SOPs for this responsibility: Recall, HHA, Medico Vigilance.
• Coordinate with relevant stakeholders to ensure the technical registration of BBVN at oversee market to be provided properly ad on time in full.
2. Quality records & reports
• Respond to provide quality reports: weekly, monthly, quarterly, yearly both local and global sides.
• Control and monitor Quality Indicator Performance and QM dashboard.
3. Project assignment
• Manages, implements and involvement assigned projects
4. Manage Team 02, Team 03
• Supervise, coach, be responsible for performance and career development guidance to team members.
5. Other tasks
• Join the defined meeting planned and unplanned, join training batches...
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.