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Manufacturing Deviation Investigation (Biopharma) HMS

Manufacturing Deviation Investigation (Biopharma) HMS

recruit express pte ltd
2-5 Years
SGD 5,000 - 7,000 per month
  • Posted 19 hours ago
  • Be among the first 10 applicants

Job Description

Location: Tuas
Contract Duration: 6 months, renewable / extendable
Salary: Up to $7,000/month
Completion Bonus: 0.5 month upon completion
Start Date: By end November 2026
Vacancies: 2

Key Responsibilities

  • Lead end-to-end manufacturing deviation investigations, from initiation and root cause determination through CAPA development and closure.

  • Conduct Root Cause Analysis (RCA) using methodologies such as 5 Whys and Fishbone / Ishikawa.

  • Facilitate cross-functional investigation meetings with Manufacturing, QA, QC, MSAT, Engineering and other stakeholders.

  • Assess manufacturing deviations, process discrepancies and potential product quality impacts to support batch disposition and release.

  • Develop, implement and monitor Corrective and Preventive Actions (CAPAs), including effectiveness checks.

  • Prepare detailed deviation investigation reports, technical assessments and GMP documentation.

  • Monitor investigation timelines and drive timely closure of deviations and CAPAs.

  • Support deviation trending, recurring issue investigations and continuous improvement initiatives.

  • Ensure investigation activities comply with GMP requirements, internal SOPs and applicable regulatory standards.

Interested candidates, please send your updated CV to [Confidential Information] OR Telegram @jocelynchan

Jocelyn Chan | Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R1331820

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Key Skills

Fishbone Ishikawa

GMP documentation

Root Cause Analysis (RCA)

5 Whys