Quality Compliance Specialist

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Duties & Responsibilities :

1. Handling complaint management by coordinate and/or perform product quality complaint investigations.

2. Coordinate and review document related quality risk management processes. Maintain risk inventory in Bekasi Site including impact assessment, lifecycle risk assessment, and ad hoc risk assessment for specific, one-time issues

3. Create and maintain the Site Risk Register (SRR), coordinate with Risk Owner to ensure up-to-date information in SRR and review SRR periodically together with Stakeholders and Risk Owner

4. Management of self-inspection in Bekasi site, as self-inspection Coordinator in Trackwise, ensure self-inspection implemented according to local & global requirement, tracking and follow up completion of self-inspection and its CAPA. Self-Inspection Coordinator also manage auditor qualification and certified as lead auditor for external and internal audit

5. Support management of Global Quality Audit and Regulatory Inspection (preparation, audit announcement, CAPA management, etc).

Locations

Bekasi, Indonesia

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time