Ho Chi Minh City, Hồ Chí Minh, Vietnam
3 days ago
Validation Process Manufacturing

1. Perform training, guide and evaluate employee in department on using the equipment, software to ensure quality compliance, safety and date integrity. According to Abbott Standard and Regulatory standards.

2. Request and commissioning tablet compression tooling, parts for encapsulation, form for sachet filling and blistering, filter for granulation lines.

3. Check the usage, storage and regular inspection.

4. Tracking maintenance, calibration of department’s equipment to ensure equipment readiness. For equipment with software operating system, collaboration with EN and IT team for routine data and system backup, user management according to the written SOP. Establish disaster recovery plan and business continuity plan for un-expected events.

5. Involving in equipment trouble shooting, build the standard procedure, work instruction for trouble shooting to reduce/ eliminate line’s downtime.

6. Involved in the qualification process for new equipment, requalification of equipment, software, and facility.

7. Cooperate with document specialist team to build and maintain database for department. Analyze data related to processes yield, manufacturing lead time, changeover. To deliver assessment, trend report and proposal for process, equipment improvement.

8. Analyze manufacturing plan to perform assessment for invidual manufacturing line and provide forecast about capacity, technical requirement, utilization rate and human resource.

9. Involved in Tech-transfer process from Technical Service department to build an effective manufacturing process and suitable with current site’s manufacturing equipment.

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