Engineer - Quality Management (Validation)

Company: B.Braun Vietnam Co. Ltd.

Job Posting Location: VN-Hanoi (Thanh Oai Complex)

Functional Area: Quality

Working Model: Onsite

Req Id: 464

Job Purpose:
Coordinate and Maintain all (re)validation activities for all processes of Plant.


Tasks & Responsibility
1. Qualification & Validation

• Responsible make (Re)validation protocols/reports
• Coordinate with related department to commit with expected validation timeline
• Involve and perform validation during Change control activity
• Involve and perform validation during Project execution
• Follow requirement of local/global SOP for (re)validation process and sharing ith with local team

2. Risk assessment

• As team member for Process risk analysis
• As team member for Equipment risk analysis
• Undertood and sharing risk analysis concept to related departments: Method, Action, Requirements…

3. Others tasks

• Create/revise local SOP according to requirement in global SOP/ ISO/ regulations
• Perform training/sharing SOP for Production/ QC/ IE to follow up.
• Make the training plan for new member/FSU and companion with them during development program

Qualification Requirements
1. Education

• Bachelor degree in Technical background.
• Nice to have ISO 13485, ISO 9001, ISO11135, ISO 11607.

2. Working Experience

• Have at least 2-year working experience and knowledge in Validation
• Risk management/ Risk analysis method

3. Nice to have:

• ETO Validation sterilization process
• Validation for Medical device manufacturing process

4. Skills required:

• Good command in English, Presentation and Communication
• Communication
• MS Office
• Presentation
• Team work