CQV QA Engineer: GMP Validation & Compliance

Coalesce Management Consulting; Singapore; On-site; SGD 78,000 - 123,000; Full time

Job summary

Coalesce Management Consulting is seeking a QA Engineer to provide independent quality oversight for CQV activities in a GMP-regulated pharma/Biopharma setting in Singapore. You will collaborate with Engineering, Validation, Manufacturing, and Quality teams to ensure facilities, utilities, and equipment are qualified and compliant.

The role requires reviewing plans, URS, risk assessments, IQ/OQ/PQ, and validation reports, and guiding project teams through change controls, CAPAs, and

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or related field.
• Experience in QA, commissioning, qualification, validation within GMP environments.
• Strong understanding of validation lifecycle for facilities, utilities, equipment, and systems.
• Familiarity with URS, DQ/IQ/OQ/PQ, risk assessments, deviations, and summary reports.
• Knowledge of GMP, data integrity, deviation management, CAPA, and change controls.
• Experience reviewing technical/validation documentation and vendor docs.

Responsibilities

• Provide QA oversight across CQV lifecycle for facilities, equipment, and systems.
• Review and approve CQV deliverables including validation plans, URS, risk assessments.
• Ensure CQV activities meet procedures, GMP, data integrity, and acceptance criteria.
• Review engineering drawings, P&IDs, specifications, vendor docs, and calibration records.
• Provide QA input during project design reviews and risk assessments.
• Assess root-cause investigations and corrective actions for CQV issues.
• Confirm critical issues are resolved before release for GMP use.
• Support audits, inspections, and inspection readiness for CQV docs.

Skills

QA oversight

Validation lifecycle

Technical review

Documentation

CAPA

Change control

Risk management

Problem solving

Education

Bachelor's degree in Engineering/Pharmaceutical Sciences/Life Sciences

Tools

Kneat

ValGenesis

TrackWise

Job description

Coalesce Management Consulting is seeking a QA Engineer to provide independent quality oversight for CQV activities in a GMP-regulated pharma/Biopharma setting in Singapore. You will collaborate with Engineering, Validation, Manufacturing, and Quality teams to ensure facilities, utilities, and equipment are qualified and compliant.

The role requires reviewing plans, URS, risk assessments, IQ/OQ/PQ, and validation reports, and guiding project teams through change controls, CAPAs, and