Quality Compliance Specialist

PT Takeda Indonesia; Kayuringinjaya; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

PT Takeda Indonesia is seeking a qualified candidate for a full-time position centered around quality management in the pharmaceuticals sector. The duties include complaint management, quality risk assessments, and self-inspection coordination to ensure compliance with local and global standards.

Responsibilities

• Handling complaint management by coordinating product quality complaint investigations.
• Coordinate document-related quality risk management processes and maintain risk inventory.
• Manage self-inspection and act as self-inspection Coordinator.

Job description

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Job Description

Duties & Responsibilities :

1. Handling complaint management by coordinating and/or performing 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 with Stakeholders and Risk Owner.
4. Manage self-inspection in Bekasi site, act as self-inspection Coordinator in Trackwise, ensure self-inspection is implemented according to local & global requirements, track and follow up on completion of self-inspection and CAPA. Manage auditor qualification and be certified as lead auditor for external and internal audits.
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

Industry: Pharmaceuticals, Biotechnology & Medical, 101-1,000 employees

Based on the corporate philosophy of "Takeda-ism" (Integrity: Fairness, Honesty, and Perseverance), developed over its long history of more than 230 years, Takeda conducts activities according to its mission to “strive towards better health for people worldwide through leading innovation in medicine.”

PT. Takeda Indonesia is looking for a potential candidate to join our team.