품질관리 약사

다음과 같이 외국계 제약회사에서 '품질관리 약사'를 찾습니다.

* Job Title: 품질관리 약사

* Position: 팀원급

* Location: 경기도

[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 (약사 면허 필수)

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