Quality Engineer (Kỹ Sư Thẩm Định Chất Lượng)

Be responsible to plan, conduct validation and follow-up re-validation in accordance with B. Braun's Validation SOPs, such as Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification and Releasing Final Validation Report for all production processes in production facility.
This includes as followings:
- Create, monitor and follow the Master Validation Plan for production processes/equipment used for producing and quality controlling at the plants of BBV - Co-ordinate with the QC, QM and Production to make a risk assessment then define and perform needed activities related to Qualification and Validation of equipment and processes according to Validation Master Plan or department's requests, as well as WHO GMP/ISO 9001/ ISO 13485 requirements
- Monitor and co-ordinate with related persons to undertake quality engineering projects with guidance from the Superior and the Management in co-operation with
Production and Quality Control department. To ensure that the validation and calibration activities are undertaken objectively based on clear technical aspects
- Assist other QM function for performing process audit arise due to corrective actions implementation
- Plan and execute qualifications and validation computerized system validation, data integrity and other as request.
- Implement Corrective Action and Preventive Action, Risk assessment, Deviation Control
- Prepare validation document to support drug registration activities (if any)
- Implement other quality issues whenever required
- Ensure that the requirements of ISO, GMP, GSP. GLP as well as legal requirements are well implemented and maintained
- Ensures that the Pharma audit programs are developed and executed effectively
- Handles complaints system from clients and product regulatory affair processes