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Quality Compliance Specialist

2 weeks ago

Bekasi, Indonesia Takeda Pharmaceutical Full time

**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