[Summary Position]
1. Develop and maintains knowledge of quality standards and GMP
2. Responsible for coordinating the activities required to meet quality standards
3. Reporting to the quality manager about GMP related issues
[Roles & Responsibilities]
1. Deviation & OOS Management
- Review and support root cause investigation
- Work closely to close the investigation timely manner
- Preparation of deviation trend report
2. Management of CAPA & Change Control
- Review and track of CAPA and Change Control
- Preparation of CAPA trend report
3. Management of Customer complaint
- Receive the complaint and support root cause investigation
- Work closely to close the investigation timely manner
- Preparation of customer complaint trend report
4. Shop Floor monitoring
- Monitoring of production area & QC lab testing activities
5. Review the document related to the operation
- Validation/Qualification) protocol/report
- Batch record review
- Preparation of Product Quality Review
- Preparation of Common Technical Document
6. GMP documents review and management
- Preparation and revision of SOPs.
[Qualfiations]
[Summary Position]
1. Develop and maintains knowledge of quality standards and GMP
2. Responsible for coordinating the activities required to meet quality standards
3. Reporting to the quality manager about GMP related issues
[Roles & Responsibilities]
1. Deviation & OOS Management
- Review and support root cause investigation
- Work closely to close the investigation timely manner
- Preparation of deviation trend report
2. Management of CAPA & Change Control
- Review and track of CAPA and Change Control
- Preparation of CAPA trend report
3. Management of Customer complaint
- Receive the complaint and support root cause investigation
- Work closely to close the investigation timely manner
- Preparation of customer complaint trend report
4. Shop Floor monitoring
- Monitoring of production area & QC lab testing activities
5. Review the document related to the operation
- Validation/Qualification) protocol/report
- Batch record review
- Preparation of Product Quality Review
- Preparation of Common Technical Document
6. GMP documents review and management
- Preparation and revision of SOPs.
[Qualfiations]