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Quality Management

2 months ago

Hanoi, Vietnam B. Braun Vietnam Co. Ltd. Full time

**Duties and responsibilities**:

- 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

**Professional competencies**:

- 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

**Personal competencies**:

- Good command in English
- Having good communication, presentation, and teamwork skills

**What we offer**:
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

**Closing date**:

- 31.03.2023

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