Senior QA Engineer: CQV, GMP Validation & Equipment

Coalesce Management Consulting; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Coalesce Management Consulting seeks a Quality Assurance Engineer to support pharmaceutical manufacturing operations with a strong focus on CQV, equipment qualification and GMP compliance. The role involves hands-on qualification on the manufacturing floor and thorough review of documentation to ensure processes operate as intended.

You will provide QA oversight across equipment, facilities and utilities lifecycle, perform IQ/OQ/PQ activities, assess deviations and CAPA, and collaborate with

Qualifications

• CQV and validation lifecycle knowledge.
• Hands-on IQ/OQ/PQ execution experience.
• Experience reviewing validation documentation from QA/engineering perspectives.
• Knowledge of cleaning validation in manufacturing.
• Understanding GMP requirements and regulatory expectations.

Responsibilities

• Provide QA oversight for CQV activities in GMP environments.
• Review IQ/OQ/PQ protocols and reports.
• Perform hands-on equipment qualification activities.
• Support commissioning and qualification activities including validation and equipment release.
• Review deviations, CAPA, change controls and validation discrepancies.
• Support qualification of equipment, facilities and utilities.
• Maintain inspection-ready validation documentation for regulatory inspections.
• Collaborate with Engineering, CQV, Validation, Manufacturing and Operations.

Skills

CQV

Equipment qualification

GMP compliance

IQ/OQ/PQ

Technical writing

Analytical

Problem-solving

Cross-functional collaboration

Education

Degree in Engineering/Life Sciences or related

Job description

Coalesce Management Consulting seeks a Quality Assurance Engineer to support pharmaceutical manufacturing operations with a strong focus on CQV, equipment qualification and GMP compliance. The role involves hands-on qualification on the manufacturing floor and thorough review of documentation to ensure processes operate as intended.

You will provide QA oversight across equipment, facilities and utilities lifecycle, perform IQ/OQ/PQ activities, assess deviations and CAPA, and collaborate with