- Singapore
全职 Senior QA Engineer 工作, 薪水 up to SGD 9,000, Coalesce Management Consulting 公司招聘中 - Ricebowl
分享
保存
工作地点
职位描述
岗位职责
Role Overview
The QA Engineer will provide independent quality oversight for Commissioning, Qualification and Validation activities within a GMP-regulated pharmaceutical or biopharmaceutical environment.
The role will work closely with Engineering, Validation, Manufacturing, Automation, Quality Control, vendors, and project teams to ensure that facilities, utilities, equipment, and associated systems are appropriately qualified, compliant, and suitable for their intended use.
Key Responsibilities
Provide QA oversight throughout the commissioning, qualification, and validation lifecycle for facilities, utilities, manufacturing equipment, laboratory equipment, and associated systems.
Review and approve CQV deliverables, including:
Validation plans and strategies
User Requirement Specifications
Quality and validation risk assessments
Design Qualification documentation
Commissioning plans and test records
Installation, Operational, and Performance Qualification protocols
Traceability matrices and turnover packages
Qualification and validation summary reports
Ensure CQV activities comply with approved procedures, GMP requirements, data-integrity principles, and predefined acceptance criteria.
Review engineering drawings, P&IDs, equipment specifications, vendor documentation, calibration records, commissioning evidence, and system handover packages.
Provide QA input during project design reviews, risk assessments, system classification, and validation-strategy discussions.
Review qualification discrepancies, protocol exceptions, test failures, and deviations arising during CQV execution.
Assess root-cause investigations, product and compliance impact, proposed corrective actions, and supporting evidence.
Confirm that critical issues are appropriately resolved before equipment or systems are released for GMP use.
Review and approve change controls, validation impact assessments, design changes, system modifications, and requalification requirements.
Provide quality guidance to project teams during protocol development, field execution, troubleshooting, and documentation closure.
Participate in project meetings and communicate quality risks, documentation gaps, and compliance requirements to relevant stakeholders.
Monitor the progress and timely closure of validation deviations, change controls, CAPAs, and qualification deliverables.
Support the final QA release and handover of qualified equipment and systems to operations.
Provide QA oversight for periodic review, requalification, and continued validation activities where required.
Support internal audits, regulatory inspections, and inspection-readiness activities involving CQV documentation and project systems.
Promote risk-based, compliant, and efficient CQV practices across assigned projects.
Candidate Requirements
Bachelor’s degree in Engineering, Pharmaceutical Science, Biotechnology, Life Sciences, or a related discipline.
Relevant experience in Quality Assurance, commissioning, qualification, validation, engineering, or project quality within the pharmaceutical, biotechnology, or another GMP-regulated industry.
Good understanding of the validation lifecycle and qualification principles for facilities, utilities, equipment, and associated systems.
Familiarity with lifecycle documents such as URS, risk assessments, DQ, IQ, OQ, PQ, traceability matrices, protocols, deviations, and summary reports.
Working knowledge of GMP, Good Documentation Practices, data integrity, deviation management, CAPA, change control, and quality risk management.
Experience reviewing technical, engineering, qualification, or validation documentation.
Able to interpret P&IDs, engineering drawings, equipment specifications, and vendor documentation.
Experience with electronic validation or quality-management systems such as Kneat, ValGenesis, TrackWise, or equivalent platforms is preferred.
Strong technical-review, investigation, problem-solving, documentation, and decision-making skills.
Able to provide independent quality guidance while working effectively with multidisciplinary project teams and external vendors.
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Functions
Engineering
Skills
Data Integrity
Project Teams
Internal Audits
Laboratory Equipment
Change Control
Communication
Readiness
Documentation
Biotechnology
Coalesce Management Consulting(CMC) is a leading international consulting partner providing technology, business change, outsourcing and operational support services across the engineering, energy, life sciences and technology sectors
The QA Engineer will provide independent quality oversight for Commissioning, Qualification and Validation activities within a GMP-regulated pharmaceutical or biopharmaceutical environment.
The role will work closely with Engineering, Validation, Manufacturing, Automation, Quality Control, vendors, and project teams to ensure that facilities, utilities, equipment, and associated systems are appropriately qualified, compliant, and suitable for their intended use.
Key Responsibilities
Provide QA oversight throughout the commissioning, qualification, and validation lifecycle for facilities, utilities, manufacturing equipment, laboratory equipment, and associated systems.
Review and approve CQV deliverables, including:
Validation plans and strategies
User Requirement Specifications
Quality and validation risk assessments
Design Qualification documentation
Commissioning plans and test records
Installation, Operational, and Performance Qualification protocols
Traceability matrices and turnover packages
Qualification and validation summary reports
Ensure CQV activities comply with approved procedures, GMP requirements, data-integrity principles, and predefined acceptance criteria.
Review engineering drawings, P&IDs, equipment specifications, vendor documentation, calibration records, commissioning evidence, and system handover packages.
Provide QA input during project design reviews, risk assessments, system classification, and validation-strategy discussions.
Review qualification discrepancies, protocol exceptions, test failures, and deviations arising during CQV execution.
Assess root-cause investigations, product and compliance impact, proposed corrective actions, and supporting evidence.
Confirm that critical issues are appropriately resolved before equipment or systems are released for GMP use.
Review and approve change controls, validation impact assessments, design changes, system modifications, and requalification requirements.
Provide quality guidance to project teams during protocol development, field execution, troubleshooting, and documentation closure.
Participate in project meetings and communicate quality risks, documentation gaps, and compliance requirements to relevant stakeholders.
Monitor the progress and timely closure of validation deviations, change controls, CAPAs, and qualification deliverables.
Support the final QA release and handover of qualified equipment and systems to operations.
Provide QA oversight for periodic review, requalification, and continued validation activities where required.
Support internal audits, regulatory inspections, and inspection-readiness activities involving CQV documentation and project systems.
Promote risk-based, compliant, and efficient CQV practices across assigned projects.
Candidate Requirements
Bachelor’s degree in Engineering, Pharmaceutical Science, Biotechnology, Life Sciences, or a related discipline.
Relevant experience in Quality Assurance, commissioning, qualification, validation, engineering, or project quality within the pharmaceutical, biotechnology, or another GMP-regulated industry.
Good understanding of the validation lifecycle and qualification principles for facilities, utilities, equipment, and associated systems.
Familiarity with lifecycle documents such as URS, risk assessments, DQ, IQ, OQ, PQ, traceability matrices, protocols, deviations, and summary reports.
Working knowledge of GMP, Good Documentation Practices, data integrity, deviation management, CAPA, change control, and quality risk management.
Experience reviewing technical, engineering, qualification, or validation documentation.
Able to interpret P&IDs, engineering drawings, equipment specifications, and vendor documentation.
Experience with electronic validation or quality-management systems such as Kneat, ValGenesis, TrackWise, or equivalent platforms is preferred.
Strong technical-review, investigation, problem-solving, documentation, and decision-making skills.
Able to provide independent quality guidance while working effectively with multidisciplinary project teams and external vendors.
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Functions
Engineering
Skills
Data Integrity
Project Teams
Internal Audits
Laboratory Equipment
Change Control
Communication
Readiness
Documentation
Biotechnology
Coalesce Management Consulting(CMC) is a leading international consulting partner providing technology, business change, outsourcing and operational support services across the engineering, energy, life sciences and technology sectors
重要安全守则
申请工作时，切勿提供您的银行或信用卡详细资料。不要转账或完成无关的在线调查问卷。如果您发现可疑内容，请举报此招聘广告。
了解更多