Senior CQV QA Engineer - GMP Validation Leader

Coalesce Management Consulting; Singapore; On-site; SGD 134,000 - 201,000; Full time

Job summary

Coalesce Management Consulting seeks a QA Engineer to provide independent QA oversight for CQV activities in a GMP-regulated environment. The role collaborates with Engineering, Validation, Manufacturing, and Quality teams to ensure qualified facilities, utilities, equipment, and systems meet GMP requirements.

Responsibilities include reviewing CQV deliverables, participating in design reviews, managing deviations and CAPAs, and supporting audits and inspections.

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical Science, Biotechnology or related field.
• Experience in Quality Assurance, commissioning, qualification, or validation in GMP environments.
• Familiarity with URS, DQ/IQ/OQ/PQ, risk assessments and validation reports.

Responsibilities

• Provide QA oversight through CQV lifecycle for facilities, utilities and equipment.
• Review and approve CQV deliverables including plans, URS and protocols.
• Participate in design reviews, risk assessments, deviations, CAPAs and change controls.
• Support audits, inspections, and readiness activities for CQV documentation.

Skills

Data Integrity

Project Teams

Internal Audits

Laboratory Equipment

Change Control

Communication

Readiness

Documentation

Biotechnology

Education

Bachelor’s degree in Engineering/Pharmaceutical Science

Tools

Kneat

ValGenesis

TrackWise

Job description

Coalesce Management Consulting seeks a QA Engineer to provide independent QA oversight for CQV activities in a GMP-regulated environment. The role collaborates with Engineering, Validation, Manufacturing, and Quality teams to ensure qualified facilities, utilities, equipment, and systems meet GMP requirements.

Responsibilities include reviewing CQV deliverables, participating in design reviews, managing deviations and CAPAs, and supporting audits and inspections.