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About the Role
Responsibilities
- Contribute to Life Science projects for Antaes Asia clients
- Lead complex technical investigations into manufacturing deviations, non-conformances, and environmental excursions
- Utilize structured Root Cause Analysis (RCA) tools (e.g., Fishbone, 5 Whys, FMEA) to identify underlying triggers
- Author comprehensive investigation reports that withstand rigorous internal and external regulatory audits (FDA, EMA, etc.)
- Perform impact assessments on product quality, safety, and efficacy
- Design and implement Corrective and Preventive Actions (CAPAs) to eliminate recurrence of deviations
- Monitor the effectiveness of implemented CAPAs through data-driven metrics
- Identify trends in manufacturing data to proactively suggest process improvements and Right First Time (RFT) initiatives
- Provide real-time engineering floor support to troubleshoot equipment malfunctions or process drift <...
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