Quality Validation Officer (Computer System Validation-CSV)- 6 Months Contract
4500 - 6000 SGDGMP Recruitment Services
About the role
To provide end-to-end CSV lifecycle support (URS, RA, IQ, OQ, PQ, RTM, VSR) and support implementation and changes for GMP systems including MES, ERP, Lab systems, and automation platforms.
Key responsibilities
Review and execution of validation protocols and test scripts
Support implementation and changes for GMP systems including MES, ERP, Lab systems, and automation platforms
Ensure compliance with GAMP5, 21 CFR Part 11, and Annex 11
Support change control, deviation, CAPA, and risk assessment activities related to the smart manufacturing project
Provide documentation support aligned with data integrity (ALCOA+) principles
Collaborate with QA, IT, Automation, and business stakeholders to ensure project goal is achieved
Support audit readiness and regulatory inspections specific to topics related to Smart Manufacturing
About you
Diploma/Degree in Engineering, Life Sciences, IT, Computer Science, Quality, or related discipline with basic understanding of Computer System Validation (CSV) and IT system/software validation
Familiarity with CSV lifecycle activities including URS, Risk Assessment, IQ, OQ, PQ, RTM, and Validation Summary Reports (VSR)
Experience supporting validation activities such as protocol execution, test script review, and validation documentation
Basic knowledge of GMP computerized systems such as MES, ERP, laboratory systems, and automation platforms
Understanding of GMP regulatory requirements including GAMP5, 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA+)
Experience supporting quality processes such as change control, deviation, CAPA, and risk assessment activities within a regulated environment
Good communication and documentation skills with the ability to collaborate with QA, IT, Automation, and business stakeholders in supporting smart manufacturing projects
GMP Technologies (S) Pte Ltd | EA License: 11C3793 | EA Personnel: Dianna| Registration No: R1327268
For a faster process, please include your availability, current salary, and expected salary in your resume.We regret that only shortlisted candidates will be notified.
6000 - 9000 SGD
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