Quality Validation Specialist - SGGK1 (8-month Contract)

Quality Validation Specialist - SGGK1 (8-month Contract)

About the Company:

Our client is a Singapore-based leader in life sciences manufacturing technology solutions.

• Role: Quality Validation Specialist - SGGK1 (8-month Contract)
• Remuneration: Up to SGD 8,000 per month
• Experience: 3+ years
• Location: Tuas, Singapore

Key Responsibilities:

• Perform an 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.

Rajkumar Renganathan

Sr. Team Lead-Recruitment | 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.