담당업무

- Oversee, manage, assure quality of products or services performed by Global CMO/CRO 

- Evaluate and qualify Global CMO/CRO and manage Approved Suppliers List.

- Review CMO manufacturing/analytical document (batch record, QC related document, protocol/report)

- Responsible for the implementation, maintenance, and improvement of QMS

- Experience with the following quality systems: Risk Management, Change Management, Tech Transfer.

- Host an audit requested by partners as a supplier of the company’s platform materials.

- Serve as a liaison with partners’ quality, facilitating smooth communication.

- Support in GxP quality systems-related training. Provide quality guidance across functions.

2)  자격요건

- 전공: 약학, 생물학, 생화학, 화학 계통 선호

    - 학력: 학사 이상

   - 경력: 7~10 년 

- Pharmaceutical/Biopharmaceutical QC/QA experience

- Strong knowledge of quality assurance principles, methodologies, and industry regulation

- General understanding of relevant FDA/EMA regulations

- Capability to documentation and record-keeping

- Ability to develop innovative/creative solution to issues.

- Adaptability and continuous learning.

3) 우대사항 :

    -  Deep understanding for latest update on drug development guidelines

    - Fluent English-speaking skill

4) 필수 업무경험 등 기타사항 :

- Experience in new drug development.

- email communication in English.

- Experience in document control.