CQV QA Engineer (GMP) – Validation & Compliance

COALESCE MANAGEMENT CONSULTING PTE. LIMITED; Singapore; On-site; SGD 110,000 - 190,000; Part time

Job summary

COALESCE MANAGEMENT CONSULTING PTE. LIMITED seeks a QA Engineer to oversee CQV activities in a GMP-regulated pharma environment.

You will collaborate with Engineering, Validation, Manufacturing, and vendors to ensure facilities and systems are qualified and fit for use. Responsibilities include reviewing CQV deliverables, risk assessments, and change controls, and ensuring data integrity and regulatory compliance.

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical Science, Biotechnology or Life Sciences.
• Experience in QA, CQV, validation within GMP-regulated environments.
• Familiarity with URS, risk assessments, DQ/IQ/OQ/PQ, and validation docs.

Responsibilities

• Provide QA oversight throughout CQV lifecycle for facilities and systems.
• Review and approve CQV deliverables, validation plans, and protocols.
• Ensure compliance with GMP, data integrity, and acceptance criteria.
• Assess deviations, investigations and CAPA; support project risk reviews.
• Provide quality guidance during design reviews and handover to operations.
• Support audits, inspections, and readiness activities.

Skills

Data Integrity

Project Teams

Internal Audits

Laboratory Equipment

Change Control

Communication

Readiness

Documentation

Biotechnology

Education

Bachelor’s degree in Engineering

Tools

Kneat

ValGenesis

TrackWise

Job description

COALESCE MANAGEMENT CONSULTING PTE. LIMITED seeks a QA Engineer to oversee CQV activities in a GMP-regulated pharma environment.

You will collaborate with Engineering, Validation, Manufacturing, and vendors to ensure facilities and systems are qualified and fit for use. Responsibilities include reviewing CQV deliverables, risk assessments, and change controls, and ensuring data integrity and regulatory compliance.