[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]

1. A registered Pharmacist in the Republic of Korea (약사 면허 보유자)

2. Professional experience – preferably more than 3 years, experience in the production and/or quality

department of a pharmaceutical company.

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