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* Job Title: Ç°Áú°ü¸® ¾à»ç
* Position: ÆÀ¿ø±Þ
* Location: °æ±âµµ
[RESPONSIBILITIES]
- Develop and maintains knowledge of quality standards and GMP
- Responsible for coordinating the activities required to meet quality standards
- Reporting to the quality manager about GMP related issues
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.
[QUALIFICATIONS]
1. Bachelor's degree or higher, majoring in Pharmacy or related field is preferred.
2. A registered pharmacist in the Republic of Korea (¾à»ç ¸éÇã Çʼö)
3. Ability to manage multiple assignment simultaneously as part of a team.
4. Good interpersonal and team skills with ability to build consensus.
5. Highly motivated with high personal and ethical standards.
6. Cross-Functional collaboration for common goal
Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Email: ceo@exdigm.com******@*******.***
U. www.exdigm.com