Kerja Sepenuh Masa, Quality Assurance Engineer di Coalesce Management Consulting - Maukerja

We are looking for a Quality Assurance Validation Engineer to provide quality oversight for equipment and system Commissioning, Qualification and Validation projects in a GMP-regulated environment. The role works closely with Engineering, Validation, Manufacturing, Automation, QC, and project teams to ensure systems are compliant, appropriately qualified, and suitable

for intended use.

Key Responsibilities

• Provide QA oversight throughout the commissioning, qualification, and validation lifecycle for equipment, facilities, utilities, and associated systems.
• Review and approve validation plans, URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, traceability documents, summary reports, and system-release packages.
• Ensure CQV execution follows approved procedures, predefined acceptance criteria, GMP expectations, and data integrity requirements.
• Assess protocol discrepancies, deviations, test failures, and corrective actions; confirm appropriate resolution before system release.
• Provide QA input to change controls, validation impact assessments, design changes, system modifications, and requalification strategies.
• Review vendor and engineering documentation, turnover packages, calibration records, drawings, and supporting evidence for completeness and traceability.
• Participate in project meetings, communicate compliance risks, and support timely closure of qualification deliverables.
• Support final QA release and handover of qualified systems, inspection readiness, internal audits, and regulatory inspections.

Requirements

• Degree or diploma in Engineering, Life Sciences, Biotechnology, Pharmaceutical Science, or a related discipline.
• Relevant QA, validation, commissioning, qualification, engineering, or project quality experience in a GMP-regulated industry.
• Knowledge of the validation lifecycle and qualification principles for equipment, facilities, utilities, or automated systems.
• Familiarity with URS, risk assessments, DQ, IQ, OQ, PQ, validation protocols, deviations, change control, and summary reports.
• Strong technical review, documentation, problem-solving, communication, and stakeholder-management capabilities