Contract Manufacturing Deviation & CAPA Lead

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

Benefits offered by this job

Completion bonus 0.5 month

Job summary

Recruit Express Pte Ltd is seeking a skilled professional to lead manufacturing deviation investigations from initiation to closure within a GMP environment. You will conduct root cause analyses, assess product quality impacts, and develop CAPAs with follow-through on effectiveness, coordinating with Manufacturing, QA, QC, MSAT, and Engineering teams.

Candidates should bring hands-on experience in end-to-end deviation investigations, strong technical writing, and stakeholder management skills,

Qualifications

• Bachelor's or Diploma in biotechnology, biochemistry, chemical engineering, pharmaceutical sciences, life sciences or related field.
• Hands-on experience leading end-to-end manufacturing deviation investigations.
• Strong knowledge of RCA, CAPA, product impact assessments and GMP operations.

Responsibilities

• Lead manufacturing deviation investigations from initiation to closure.
• Conduct root cause analysis and assess potential product quality impacts.
• Develop CAPAs and monitor their effectiveness.
• Coordinate investigations with Manufacturing, QA, QC, MSAT and Engineering teams.
• Prepare investigation reports and ensure timely closure in line with GMP requirements.
• Support deviation trending and continuous improvement.

Skills

Root cause analysis

Problem solving

Stakeholder management

Technical writing

GMP operations

Education

Diploma/Degree in Biotechnology/Science/Engineering

Tools

TrackWise

Veeva Vault

Job description

Recruit Express Pte Ltd is seeking a skilled professional to lead manufacturing deviation investigations from initiation to closure within a GMP environment. You will conduct root cause analyses, assess product quality impacts, and develop CAPAs with follow-through on effectiveness, coordinating with Manufacturing, QA, QC, MSAT, and Engineering teams.

Candidates should bring hands-on experience in end-to-end deviation investigations, strong technical writing, and stakeholder management skills,