Jobscope:

• To provide end-to-end CSV lifecycle support (URS, RA, IQ, OQ, PQ, RTM, VSR)
• 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

Requirements:

• 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.



To find out more about this opportunity, please contact Fiona Koh; fiona.koh@gmprecruit.com

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239