Quality Validation Specialist (GMP, CSV)

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.

If suitable resources - Please reach out to [Confidential Information] ; [HIDDEN TEXT]

Quess Selection & Services, Singapore

EA Licence Number: 23C2060 Registration ID is R1983662

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This is in partnership with the Employment and Employability Institute Pte Ltd (e2i).

e2i is the empowering network for workers and employers seeking employment and employability solutions. e2i serves as a bridge between workers and employers, connecting with workers to offer job security through job-matching, career guidance and skills upgrading services, and partnering employers to address their manpower needs through recruitment, training, and job redesign solutions. e2i is a tripartite initiative of the National Trades Union Congress set up to support nation-wide manpower and skills upgrading initiatives. By applying for this role, you consent to Quesscorp Singapore's PDPA and e2i's PDPA