GMP Deviations Lead - RCA, CAPA & Investigations

Recruit Express Pte Ltd; Singapore; On-site; SGD 71,000 - 85,000; Part time

Job summary

Recruit Express Pte Ltd is seeking a candidate to join a GMP-regulated biopharmaceutical pipeline in Singapore. The role leads end-to-end manufacturing deviation investigations, identifies root causes, and develops CAPAs for closure under a 6-month contract.

The incumbent will collaborate with Manufacturing, QA, QC, MSAT and Engineering to ensure GMP compliance, perform RCA with 5 Whys and Fishbone, and prepare technical reports and documentation. This position is based in Singapore.

Qualifications

• 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.

Responsibilities

• 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.

Skills

RCA

CAPA management

GMP compliance

Cross-functional collaboration

Technical writing

Problem solving

Education

Biotechnology/related degree

Tools

TrackWise

Veeva Vault

Job description

Recruit Express Pte Ltd is seeking a candidate to join a GMP-regulated biopharmaceutical pipeline in Singapore. The role leads end-to-end manufacturing deviation investigations, identifies root causes, and develops CAPAs for closure under a 6-month contract.

The incumbent will collaborate with Manufacturing, QA, QC, MSAT and Engineering to ensure GMP compliance, perform RCA with 5 Whys and Fishbone, and prepare technical reports and documentation. This position is based in Singapore.