Technical Specialist (Manufacturing Deviations) @ TUAS #HFT

Your tasks

• Lead end-to-end manufacturing deviation investigations in a GMP-regulated biopharmaceutical environment.
• Own investigations from initiation and root cause identification through CAPA development, implementation and closure.
• Conduct Root Cause Analysis (RCA) using methodologies such as 5 Whys and Fishbone Analysis.
• Facilitate cross-functional investigations with Manufacturing, QA, QC, MSAT and Engineering teams.
• Assess manufacturing deviations, process discrepancies and potential product quality impacts.
• Develop and monitor CAPAs, including effectiveness checks to prevent recurrence.
• Prepare technical investigation reports, assessments and supporting GMP documentation.
• Track investigation timelines and drive timely closure of deviations and CAPAs.
• Support deviation trending, recurring issue investigations and continuous improvement initiatives.
• Ensure compliance with GMP requirements, internal SOPs and regulatory standards.

Requirements

• Diploma or Degree in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Life Sciences or a related discipline.
• Prior experience in biopharmaceutical or pharmaceutical manufacturing, preferably in biologics, vaccines, API or drug substance manufacturing.
• Strong hands-on experience independently leading end-to-end manufacturing deviation investigations is essential.
• Proven experience in RCA, CAPA management, product impact assessments and deviation closure.
• Good understanding of GMP manufacturing processes, production equipment and shop-floor operations.
• Experience working with cross-functional stakeholders to resolve manufacturing issues.
• Strong technical writing, analytical and problem-solving skills.
• Familiarity with TrackWise, Veeva Vault or other electronic quality management systems is advantageous.
• Able to manage multiple investigations independently and work in a dynamic manufacturing environment.

What we offer

*Contract: 6 months (renewable / extendable) Salary: Up to $7,000/month Completion Bonus:** 0.5-month completion bonus

How to apply

For interested candidates, please submit your latest resume to jacquelinefong@recruitexpress.com.sg.

Other

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