Senior QA Engineer - CQV & GMP Validation Expert

Coalesce Management Consulting; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

Coalesce Management Consulting is seeking a Quality Assurance Engineer to support pharmaceutical and biopharmaceutical manufacturing operations with a strong focus on CQV, equipment qualification and GMP compliance.

The successful candidate will provide QA oversight across the lifecycle of manufacturing equipment, facilities and utilities, while also supporting hands-on qualification and validation activities on the manufacturing floor.

Qualifications

• Degree in Engineering, Pharmaceutical Science, Biotechnology, Life Sciences or related field.
• Experience in pharmaceutical, biopharmaceutical or GMP regulated manufacturing.
• Strong CQV and equipment qualification experience.
• Hands-on IQ/OQ/PQ activities execution or support.
• Good understanding of GMP, validation lifecycle, deviations, CAPA and change control.
• Experience reviewing technical and validation documentation from QA/engineering perspectives.

Responsibilities

• Provide QA oversight for CQV activities within a GMP-regulated environment.
• Review and approve IQ, OQ and PQ protocols and reports, risk assessments and technical documentation.
• Perform and support hands-on equipment qualification activities for project and operations.
• Support commissioning and qualification activities including FAT, SAT, IQ/OQ/PQ and equipment release.
• Review and assess deviations, CAPA, change controls and validation discrepancies with proper investigations.
• Support qualification of manufacturing equipment, facilities and utilities.
• Provide QA oversight for equipment maintenance, calibration and qualification status.
• Maintain inspection-ready validation documentation and support audits.

Job description

Coalesce Management Consulting is seeking a Quality Assurance Engineer to support pharmaceutical and biopharmaceutical manufacturing operations with a strong focus on CQV, equipment qualification and GMP compliance.

The successful candidate will provide QA oversight across the lifecycle of manufacturing equipment, facilities and utilities, while also supporting hands-on qualification and validation activities on the manufacturing floor.