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The company is seeking a Technical Specialist (Manufacturing Deviations) to lead end-to-end manufacturing deviation investigations within a GMP-regulated biopharmaceutical environment. The role requires ownership of investigations from initiation through CAPA development, with proficiency in root cause analysis methods such as 5 Whys and Fishbone, and the ability to facilitate cross-functional reviews with Manufacturing, QA, QC, MSAT, and Engineering. Key responsibilities include assessing deviations and driving investigations to closure, with a focus on implementing sustained CAPA. The position is a 6-month contract (renewable/extendable) with a salary up to 7,500 per month and a 0.5-month completion bonus.
This summary is AI-generated and may contain inaccuracies. Please refer to the full job description below.
[This job https://singapore.job-q.com/jobs/detail/technical-specialist-manufacturing-deviations-tuas-hft-40847 first appeared in Job-Q.com on 30 Oct 2026]
Contract: 6 months (renewable / extendable)
Salary: Up to $7,000/month
Completion Bonus: 0.5-month completion bonus
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.
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.
For interested candidates, please submit your latest resume to .
Jacqueline Fong Hsin Ting (R21103226)
Recruit Express Pte Ltd
Company Reg. No. 199601303W
EA License Number: 99C4599.
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