GMP Deviation Investigator & CAPA Lead

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

Job summary

Recruit Express Pte Ltd is seeking a capable professional to lead end-to-end manufacturing deviation investigations in a GMP-regulated biopharmaceutical environment in Singapore. The role focuses on ownership from initiation through CAPA development and closure, utilizing RCA methods and cross-functional collaboration.

You will prepare GMP documentation, monitor timelines, and drive timely closure of deviations and CAPAs while supporting continuous improvement and regulatory compliance in

Qualifications

• Diploma or Degree in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Life Sciences or a related discipline.
• Experience in biopharmaceutical manufacturing, preferably biologics, vaccines, API or drug substance.
• Strong hands-on experience leading end-to-end deviation investigations.
• Proven RCA, CAPA management and deviation closure experience.
• Good GMP understanding and shop-floor operations.
• Experience working with cross-functional stakeholders to resolve manufacturing issues.
• Strong technical writing and analytical skills.
• Familiarity with TrackWise or Veeva Vault is advantageous.
• Able to manage multiple investigations independently 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 knowledge

Root cause analysis

Cross-functional collaboration

Technical writing

Education

Biotechnology / Life sciences degree

Tools

TrackWise

Veeva Vault

Job description

Recruit Express Pte Ltd is seeking a capable professional to lead end-to-end manufacturing deviation investigations in a GMP-regulated biopharmaceutical environment in Singapore. The role focuses on ownership from initiation through CAPA development and closure, utilizing RCA methods and cross-functional collaboration.

You will prepare GMP documentation, monitor timelines, and drive timely closure of deviations and CAPAs while supporting continuous improvement and regulatory compliance in