Quality Validation Officer (Computer System Validation-CSV)- 6 Months Contract

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.