- Islandwide (Singapore) Singapore

Working Location
Job Description
Responsibilities
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 *************
Anna Chen jiaxin
CEI No: R25157621
Recruit Express Pte Ltd
EA License: 99C4599
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