Quality Validation Specialist

Validation Quality Specialist

Location: Singapore, Tuas.
Industry: Pharmaceutical Manufacturing | Life Sciences

The successful candidate will be responsible for reviewing validation lifecycle documentation and qualification deliverables across Equipment, Utilities, Facilities, and Automation Systems to ensure compliance with GMP requirements, site procedures, Annex 1 expectations, and industry best practices.

Key Responsibilities

• Perform independent quality review of validation lifecycle documentation.
• Review Equipment Qualification deliverables including IQ, OQ, PQ protocols and reports.
• Review Utility Qualification documentation for GMP-critical utility systems.
• Review Facility Qualification documentation with focus on cleanroom and Annex 1 compliance requirements.
• Review Automation and Computer System Validation (CSV) documentation, including:
• Validation Plans
• User Requirements Specifications (URS)
• Functional Specifications (FS/DS)
• Risk Assessments
• Traceability Matrices
• IQ/OQ/PQ Protocols
• Validation Summary Reports
• Ensure validation deliverables comply with GMP, Data Integrity, GAMP5, Annex 1, and site quality requirements.
• Identify documentation gaps, compliance risks, and quality concerns during review activities.
• Support resolution of validation documentation comments and quality observations.
• Collaborate with Validation, CQV, Automation, Engineering, Operations, and Quality teams.
• Support audit readiness and inspection preparation activities.
• Promote consistency and compliance across validation documentation packages.

Requirements

• Degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related discipline.
• Experience within pharmaceutical, biotechnology, medical device, or GMP-regulated manufacturing environments.
• Strong understanding of validation lifecycle methodologies and qualification practices.
• Hands-on experience reviewing validation documentation for:
• Equipment Qualification
• Utility Qualification
• Facility Qualification
• Automation / CSV Qualification
• Good knowledge of GMP regulations, Annex 1 requirements, GAMP5 principles, and Data Integrity expectations.
• Familiarity with risk-based validation approaches and lifecycle validation concepts.
• Strong technical document review and compliance assessment skills.
• Ability to identify quality gaps and provide practical compliance recommendations.
• Ability to work independently within multidisciplinary project teams.