[ROLES & ​RESPONSIBILITIES]

1. Deviation ​& ​OOS Management

- Management ​of Deviation (receive the ​deviation ​documents, review, ​and support root ​cause investigation)

- Work ​closely ​to close ​the ​investigation ​on time

- Preparation of ​deviation ​trend report

2. Management of ​CAPA ​& ​Change Control

- Receives CAPA ​concerning audit ​observations, ​complaints, deviations, ​PQR corrective ​actions, ​etc.

- Receives change ​control requests ​and conducts impact assessment in case of GMP-related changes that occur, and manages the change progress status

- Preparation of CAPA trend report

- Updates on CAPA status; conducts efficiency assessment on completed CAPA.

3. Management of Customer complaint

- Management of complaints from customers, B2B partners (confirmation of complaint, review and support root cause investigation)

- Work closely to close the investigation on time

- Preparation of customer complaint trend report

4. Shop Floor monitoring

- Monitoring of production area & QC lab testing activities

5. EMQS Management

- Handling and managing issues regarding EQMS

- staff training for EQMS use, change EQMS authorities of employees.

6. Review the document related to the operation

- Validation/Qualification protocol/report

- Batch record review

- Preparation of Common Technical Document

7. Trend Analysis

- Purified water, environmental monitoring trend analysis of Gongju Plant

8. QA common tasks

- Creating and Updating of SOPs.

- Preparation of the required regulatory, customer, and external audit

[QUALIFICATIONS]

1. Bachelor’s Degree or above preferably in chemistry, biology, pharmacy, or related

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. To be well acquainted with the MFDS standards and preferably also European standards on Good Manufacturing Practice(EU-GMP), as well as other international GMP standard

5. Good interpersonal and team skills with ability to build consensus.

6. Highly motivated with high personal and ethical standards.

7. Cross-Functional collaboration for common goal