The Quality Compliance Specialist will manage product quality complaints, coordinate self-inspections, and support quality audits at the Bekasi site.
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's Privacy Notice and 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
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
Top Skills
Quality Risk Management Processes
Trackwise
Similar Jobs at Takeda
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
The role involves promoting and selling the Takeda Dengue Vaccine, achieving sales targets, building relationships with healthcare professionals, and executing marketing activities.
What you need to know about the Singapore Tech Scene
The digital revolution has driven a constant demand for tech professionals across industries like software development, data analytics and cybersecurity. In Singapore, one of the largest cities in Southeast Asia, the demand for tech talent is so high that the government continues to invest millions into programs designed to develop a talent pipeline directly from universities while also scaling efforts in pre-employment training and mid-career upskilling to expand and elevate its workforce.