Manufacturing Engineer (Deviations)
External
Antaes Asia · One Marina Boulevard, SingaporePrepare for this interview
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About the role
- 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. - Collaborate with Quality Assurance(QA) and Production teams to ensure all activities align with Standard Operating Procedures (SOPs). - Participate in the drafting and revision of SOPs, Batch Records, and Validation protocols. - Contribute to the promotion of Antaes services on top of assistance provided to clients
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