GMP QA Deviation Investigator - Pharma (6mo, Up to $7k)

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

Job summary

Recruit Express Pte Ltd seeks a QA Technical Specialist to lead end-to-end deviation investigations in a GMP biopharma setting. This role manages investigations from initiation to root cause and CAPA closure, coordinating cross-functional teams across Manufacturing, QA, QC, MSAT and Engineering.

The ideal candidate holds a Life Sciences degree with 5+ years of QA ops experience in pharma, and will ensure timely batch disposition, document GMP reports, and compliance with SOPs and regulatory

Qualifications

• Min Degree in Life Sciences or similar w min 5 yrs of relevant experience & QA ops in pharmaceutical industry

Responsibilities

• Lead and manage end-to-end manufacturing deviation investigations within a GMP-regulated biopharmaceutical manufacturing environment.
• Act as the deviation owner, driving investigations from initiation through root cause determination, CAPA development and closure.
• Conduct Root Cause Analysis (RCA) using structured investigation methodologies such as 5 Whys, Fishbone/Ishikawa and other relevant tools.
• Facilitate and lead cross-functional investigation meetings involving Manufacturing, QA, QC, MSAT, Engineering and other relevant stakeholders.
• Assess manufacturing deviations, process discrepancies and potential product quality impacts to support timely batch disposition and release.
• Develop, implement and monitor Corrective and Preventive Actions (CAPAs), including effectiveness checks to prevent recurrence.
• Prepare comprehensive deviation investigation reports, technical assessments and supporting GMP documentation.
• Monitor investigation timelines, manage outstanding actions and ensure timely closure of deviations and CAPAs.
• Support deviation trending, recurring issue investigations and continuous improvement initiatives.
• Ensure all investigation activities comply with GMP requirements, internal SOPs and applicable regulatory standards.

Skills

Root Cause Analysis

CAPA

GMP Compliance

Deviations Investigation

Education

Life Sciences degree

Tools

5 Whys

Ishikawa diagram

CAPA process

Job description

Recruit Express Pte Ltd seeks a QA Technical Specialist to lead end-to-end deviation investigations in a GMP biopharma setting. This role manages investigations from initiation to root cause and CAPA closure, coordinating cross-functional teams across Manufacturing, QA, QC, MSAT and Engineering.

The ideal candidate holds a Life Sciences degree with 5+ years of QA ops experience in pharma, and will ensure timely batch disposition, document GMP reports, and compliance with SOPs and regulatory