Sabastanus Kait

Background

About Sabastanus Kait

My Job Scope and Experiences:1. Implement QA activities as per established procedures and maintain compliance in the designated manufacturing area and warehouse.2. Supervise QA activity in designated manufacturing area and warehouse.3. To ensure online activities are carried out as per procedure/specification.4. To ensure products are released on timely basis meeting Customer and Regulatory requirements.5. Organize Quality meetings on regular basis with relevant departments.6. Preparation and publication of Quality analytical reports on timely basis.7. Raise process non-conformance report or CAPA whenever required.8. Support manufacturing in CAPA investigation and customer complaints whenever necessary.9. Verify corrective action for CAPA and follow up on the effectiveness of the correction actions.10. Review customer complaints investigation reports. To ensure the relevant procedure are reviewed and revised to current quality system requirements.12. To conduct internal process audit in production areas whenever required.13. To ensure Device history Record (DHR) is review prior to final release and certification.14. To ensure the implementation and maintenance within the workplace of an effective management for occupational safety and health consistent with the requirements of Occupational Safety and Health Act 1994.15. Coordinate customer return good.16. Coordinate Quality improvement project inside production floor.17. review and verify shipment list and certificates.18. Control and release product after Sterilization process.• Supporting process engineering team to conduct Root causes analysis for manufacturing defect in HME Yield improvement project.• Updating Manufacturing specification to align with actual production practices. • Provide support in Validation activity starting with protocol, OQ until PQ stage.• Actively involved in continues improvement activity in HME including primary Kaizen waste reduction project (WOW) and Overall Equipment Effectiveness (OEE).• Provide technical support to reduce Auto Capping machine downtime and product failure base on Failure Mode and Effect Analysis (FMEA).• Provide analytical testing for packing material bonding test using Universal Tensile Machine (Instron UTM).• Analyze validation and verification data statistically using MiniTab Software and provide Cpk analysis for required equipment or process.• Working with supplier and vendors for Corrugation Machine refurbishment.• Supporting process engineering team in URS preparation for new Multivac R245 packaging machine.