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
- Skills required:
- Good command in English, Presentation and Communication
- Communication
- MS Office
- Presentation
- Team work
