Not specified (assumed to be hybrid or onsite based on nature of role)
Root cause analysis tools like fishbone
Fda and ema regulatory audit experience
Corrective and preventive actions (capa) design
Antaes Asia PTE. LTD. is seeking a Manufacturing Engineer to lead technical investigations into manufacturing deviations and ensure compliance with regulatory standards. The ideal candidate will utilize structured Root Cause Analysis tools to improve processes and maintain product quality, while collaborating closely with Quality Assurance and Production teams
Job Summary
Lead complex technical investigations into manufacturing deviations, non-conformances, and environmental excursions.
Author comprehensive investigation reports that withstand rigorous internal and external regulatory audits such as FDA and EMA.
Design and implement Corrective and Preventive Actions (CAPAs) to eliminate recurrence of deviations while monitoring effectiveness.
Matching Summary
Match Score: 85
Antaes Asia PTE. LTD. is seeking a Manufacturing Engineer to lead technical investigations into manufacturing deviations and ensure compliance with regulatory standards. The ideal candidate will utilize structured Root Cause Analysis tools to improve processes and maintain product quality, while collaborating closely with Quality Assurance and Production teams.
Skills & Requirements
Must-have
Root Cause Analysis tools like Fishbone
FDA and EMA regulatory audit experience
Corrective and Preventive Actions (CAPA) design
Impact assessment on product quality
Standard Operating Procedures (SOPs) drafting
Nice-to-have
Data-driven metrics for CAPA monitoring
Process improvement and Right First Time initiatives