- Tanjong Pagar Central Region (Singapore) Singapore
Kerja Sepenuh Masa Validation Engineering Lead, Gaji tinggi SGD 9,000 di WUXI XDC SINGAPORE PRIVATE LIMITED Central Region (Singapore) - Maukerja
Validation Engineering Lead
WUXI XDC SINGAPORE PRIVATE LIMITED
Kongsi
Simpan
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
About the role
The Lead, Quality Engineering & Support is responsible for providing strategic and operational quality leadership for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems, Warehouse, and Quality Control (QC) operations. This role ensures that all supported functions operate in compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines, Data Integrity requirements, and company quality standards. The incumbent serves as the Site Data Integrity (DI) Champion and is accountable for the quality oversight of qualification and validation activities, engineering and computerized system lifecycle management, warehouse and laboratory compliance, risk management, inspection readiness, and continuous improvement initiatives.
Key responsibilities
Provide quality oversight for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems (CSV), Warehouse, and Quality Control operations
Ensure SOPs, Quality Risk Assessment, reports, specification and quality records comply with FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Data Integrity requirements, and company quality standards
Provide independent quality decisions to ensure product quality, patient safety, data integrity, and regulatory compliance
Review and approve deviations, investigations, CAPAs, change controls, Quality Risk Assessments (QRAs), gap assessments, SOPs, protocols, validation documentation, and technical reports
Support and participate in audit and inspection readiness programs and represent Quality Operations during client audits and regulatory inspections
Review and approve qualification and validation lifecycle activities, including facilities, utilities, equipment, HVAC, process gases, computerized systems, process validation, and cleaning validation
Serve as the Site Data Integrity (DI) Champion and lead and maintain the site's Data Integrity Governance Program
Promote and embed ALCOA+ principles across the organization
Lead remediation activities and monitor effectiveness of corrective and preventive actions
Drive a culture of quality, compliance, inspection readiness, operational excellence, and continuous improvement
About you
Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, Computer Science, Information Systems, or a related discipline
Minimum 10 years of experience in pharmaceutical, biotechnology, biologics, ADC, or CDMO environments
Minimum 5 years of leadership experience within Quality Assurance, Validation, Engineering Quality, QC Quality, or related GMP functions
Strong knowledge of FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Annex 11, 21 CFR Part 11, and Data Integrity requirements
Expertise in validation lifecycle management, Quality Risk Management, compliance gap assessments, and GMP quality systems
Strong understanding of engineering systems, utilities, HVAC, process gases, computerized systems, warehouse operations, and QC laboratory processes
Excellent quality decision-making, stakeholder management, problem-solving, and communication skills
Ability to balance business objectives while maintaining the highest standards of quality and regulatory compliance
The Lead, Quality Engineering & Support is responsible for providing strategic and operational quality leadership for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems, Warehouse, and Quality Control (QC) operations. This role ensures that all supported functions operate in compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines, Data Integrity requirements, and company quality standards. The incumbent serves as the Site Data Integrity (DI) Champion and is accountable for the quality oversight of qualification and validation activities, engineering and computerized system lifecycle management, warehouse and laboratory compliance, risk management, inspection readiness, and continuous improvement initiatives.
Key responsibilities
Provide quality oversight for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems (CSV), Warehouse, and Quality Control operations
Ensure SOPs, Quality Risk Assessment, reports, specification and quality records comply with FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Data Integrity requirements, and company quality standards
Provide independent quality decisions to ensure product quality, patient safety, data integrity, and regulatory compliance
Review and approve deviations, investigations, CAPAs, change controls, Quality Risk Assessments (QRAs), gap assessments, SOPs, protocols, validation documentation, and technical reports
Support and participate in audit and inspection readiness programs and represent Quality Operations during client audits and regulatory inspections
Review and approve qualification and validation lifecycle activities, including facilities, utilities, equipment, HVAC, process gases, computerized systems, process validation, and cleaning validation
Serve as the Site Data Integrity (DI) Champion and lead and maintain the site's Data Integrity Governance Program
Promote and embed ALCOA+ principles across the organization
Lead remediation activities and monitor effectiveness of corrective and preventive actions
Drive a culture of quality, compliance, inspection readiness, operational excellence, and continuous improvement
About you
Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, Computer Science, Information Systems, or a related discipline
Minimum 10 years of experience in pharmaceutical, biotechnology, biologics, ADC, or CDMO environments
Minimum 5 years of leadership experience within Quality Assurance, Validation, Engineering Quality, QC Quality, or related GMP functions
Strong knowledge of FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Annex 11, 21 CFR Part 11, and Data Integrity requirements
Expertise in validation lifecycle management, Quality Risk Management, compliance gap assessments, and GMP quality systems
Strong understanding of engineering systems, utilities, HVAC, process gases, computerized systems, warehouse operations, and QC laboratory processes
Excellent quality decision-making, stakeholder management, problem-solving, and communication skills
Ability to balance business objectives while maintaining the highest standards of quality and regulatory compliance
Peringatan Penting
Jangan pernah kongsikan maklumat bank atau kad kredit anda semasa memohon pekerjaan. Elakkan membuat sebarang pembayaran atau mengisi survey yang tidak berkaitan. Jika ada yang mencurigakan, sila laporkan iklan pekerjaan ini segera.
Lebih Lanjut