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Attractive performance bonus & salary review
International working environment with many training opportunities
Company bus from the central to company
Mô Tả Công Việc
1. Qualification & Validation activity
• To create, monitor and follow the Master Validation Plan for production processes/ equipment used for producing and quality controlling at the plants of BBVN
• To 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.
• To plan and execute qualifications and validation computerized system validation, data integrity and other as request.
• To involve in change control activities
2. Risk assessment:
• To 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/ DIR requirements.
3. Project activity:
• To be a member of projects and responsible for tasks which are related to validation
4. Deviation Control:
• To implement CAPA/ DIR with the team
• To involve in Deviation permit/ Concession release
5. Other tasks:
• To create, revise and train SOP
• To implement calibration
• To make training plan for new member
Xem toàn bộ Mô Tả Công Việc
• To create, monitor and follow the Master Validation Plan for production processes/ equipment used for producing and quality controlling at the plants of BBVN
• To 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.
• To plan and execute qualifications and validation computerized system validation, data integrity and other as request.
• To involve in change control activities
2. Risk assessment:
• To 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/ DIR requirements.
3. Project activity:
• To be a member of projects and responsible for tasks which are related to validation
4. Deviation Control:
• To implement CAPA/ DIR with the team
• To involve in Deviation permit/ Concession release
5. Other tasks:
• To create, revise and train SOP
• To implement calibration
• To make training plan for new member
Yêu Cầu Công Việc
• Graduating from universities with technical background
• Having knowledge about 6-sigma, CFR 21 part 11, GAMP 5, 7 QC tools. ISO 13485, ISO 9001 are plus
• At least 1–3-year experience in Validation and Risk Management
• Good command in English
• Having good communication, presentation, and teamwork skills
• Having knowledge about 6-sigma, CFR 21 part 11, GAMP 5, 7 QC tools. ISO 13485, ISO 9001 are plus
• At least 1–3-year experience in Validation and Risk Management
• Good command in English
• Having good communication, presentation, and teamwork skills
Địa Điểm Làm Việc
Thanh Oai Industrial Zone, Khu công nghiệp, Bích Hòa, Thanh Oai, Hà Nội, Việt Nam
