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

GMP TECHNOLOGIES (S) PTE LTD; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

GMP Technologies (S) Pte Ltd in Singapore is seeking a dedicated Validation Specialist to provide end-to-end CSV lifecycle support including URS, IQ, OQ, PQ, RTM, and VSR for GMP systems such as MES, ERP, and lab systems.

You will collaborate with QA, IT, and business stakeholders to ensure data integrity and regulatory readiness, while supporting change control, deviations, CAPA, and risk assessments in a smart manufacturing environment.

Qualifications

• Diploma/Degree in Engineering, Life Sciences, IT, Computer Science, Quality, or related discipline with basic understanding of CSV and IT system validation
• Familiarity with CSV lifecycle activities including URS, Risk Assessment, IQ, OQ, PQ, RTM, and 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

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

Skills

CSV lifecycle

URS & Risk

IQ/OQ/PQ

RTM/VSR

GAMP5

21 CFR Part 11

Annex 11

ALCOA+

Education

Diploma/Degree in Engineering/Life Sciences/IT/CS/Quality

Tools

MES

ERP

Lab systems

Automation platforms

Job description

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

We regret that only shortlisted candidates will be notified.