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- 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
ANTAES ASIA PTE. LTD.
Antaes Asia Pte Ltd is specialised in management and technology consulting.
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