JOB PURPOSE:
- To manage the overall introduction of new product
- To ensure that affiliate operations are conducted to an adequate level of quality system in conformity with regulatory and internally defined standards

KEY ACCOUNTABILITIES:
1. New product launch readiness
1) Managing the overall introduction of new product by controlling change control

2) Preparing launch by attending regular launch meeting and sharing quality issue

3) Coordinating method transfer
- Cooperate with Sending Unit (SU) and Receiving Unit (RU) to keep the timeline of the technical transfer
- Coordinate import of all the required materials (reference standards, reagents and samples) by preparing the required documents depend on its origin
- Review the protocol and the report for analytical method transfer
- Manage milestone
- If necessary, manage purchasing equipment

4) Setting first QC release test
- Review test method SOPs
- Control stock of all the materials
- Mediate lead time for test

5) Managing pre-approval on-site/virtual GMP inspection by communicating with MFDS and overseas manufacturing site
- Act as a point of contact between MFDS inspectors and the manufacturing iste

- Arrange the schedule and the required logistics (interpreters, accommodation, transportation, etc.)

- Participate on-site/virtual inspection as the affiliate responsible and provide necessary support to both MFDS inspectors and the manufacturing site
- Arrange preparation and submission of CAPA response

2. Quality System
1) Quality Document management (Provide support as back-up)

(1) Procedure management as Local SME

(2) Local QD Management

- Prepare and monitor local quality QD plan and report

(3) Monitoring global QD update and managing QD assessment

- Monitoring global QD creation/revision and assigning the assessment to the relevant Local SME

- Monitoring and managing QD assessment to ensure completion in timely manner

(4) Content Management System (Veeva) management

- Local focal point as a key user

2) GxP document and record management

- Procedure management as Local SME

- Monitoring quality document inventory list and perform periodic review

- Control the access to office archiving room and perform annual access review

- Coordinate transfer/retrieval/destruction of paper document and record to IMK (external document archiving party)

- Handwritten and electronic signature management (including Adobe GxP e-sign system access)

- Quality Monthly Data-day

3) Training

(1) Procedure management as Local SME

(2) Training management (Provide support as back-up)

- Manage and monitor GxP training matrix to be updated in timely manner by each country GxP functions

- Establish quality annual training plan and monitor planned training completion as per the annual plan.

- Coordinate quality individual training plan to be established according to GxP training matrix

- Provide AR support for training completion and KPI monitoring

- Provide necessary support for GxP training management to quality and country GxP functions according to local training management procedure

- Guide to GxP division to maintain up-to-date organizational chart

4) Change Control

(1) Procedure management as Local SME (Provide support as back-up)

(2) Change Control process and system (Veeva) management

- Coordinate change control electronic system deployment and maintenance (Provide support as back-up)

- Manage Change Control records as Change Plan Owner in the system

- Weekly completion monitoring (Provide support as back-up)

- Local focal point as a key user (Provide support as back-up)

5) Deviation & CAPA

(1) Procedure management as Local SME (Provide support as back-up)

(2) Deviation & CAPA process and system (Veeva) management

- Coordinate Deviation & CAPA electronic system deployment and maintenance (Provide support as back-up)

- Review and approve Deviation & CAPA as Quality Approver in the system

- Weekly completion monitoring (Provide support as back-up)

- Local focal point as a key user (Provide support as back-up)

6) HA Inspection & Country GxP Audit

(1) Inspection Readiness Tool (IRT) (Provide support as back-up)

- IRT Process management (Global instruction cascade and training)

- Manage IRT Exercise as IRT coordinator

- Report IRT results and mitigation action progress at country quality review

(2) Inspection management

- Inspection preparation & coordination with related country functions/owners

- Maintain Inspection readiness Kit and provide necessary training

- Inspection and audit record maintenance as site responsible in the electronic system (Veeva)

(3) Procedure management as Local SME

(4) Annual control self-assessment (CSA)

- Data input, response, follow-up regarding quality system

7) Self-inspection

(1) Procedure management as Local SME

(2) Self-Inspection management (Provide support as back-up)

- Planning and monitoring annual self-inspection

- Monitoring CAPA list

(3) Conduct assigned self-inspection as auditor

8) Managing computerized system

- Procedure management as Local SME

- Evaluation of local GxP computerized system and follow up required local actions according to Global SOPs

- Manage and update local inventory list according to the global procedures (Provide support as back-up)

9) Country Quality Review and KPI management

- Annual quality review data preparation as Quality System SME

- KPI reporting data preparation as Quality System SME

- Other quality performance data preparation as Quality System SME

10) Project management

- Provide support to country quality system manager and global quality for project management related to NPI and Quality system

JOB-HOLDER REQUIREMENTS:

Education
- Bachelor’s degree or above in science
- Pharmacist is preferred.

Experience & knowledge
- at least 5 years experiences in pharmaceutical industries
- Knowledge about pharmaceutical regulation and quality assurance system

Core competencies /skills
- English/Korea proficiency is essential
- Project management skills and cross-functional competence
- Presentation skills and strong communication skills
- Excellence in Word, Excel, PowerPoint

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