Computer Systems Validation (CSV) Specialist - 1 Year Contract | Pharma MNC

About the role

Perform end-to-end Computer System Validation (CSV) for GMP computerized systems. You will develop and review validation documents, maintain validation plans and test scripts, perform Data Process Mapping and Data Vulnerability Assessments, and support audit trail review and data integrity activities.

Key responsibilities

• Perform end-to-end Computer System Validation (CSV) for GMP computerized systems
• Develop and review validation documents including URS, FDS, SDS, HDS, DQ, IQ and OQ
• Develop and maintain validation plans, test scripts and traceability documentation
• Perform Data Process Mapping (DPM) and Data Vulnerability Assessments (DVA)
• Support Audit Trail Review Determination and data integrity activities
• Support validation of systems such as Cytiva UNICORN and Telstar LyoSuite
• Review and execute qualification/validation protocols and manage deviations identified during testing
• Support system changes, upgrades, configuration changes and change control activities
• Work closely with QA, IT/OT, Automation, Engineering, system owners and vendors
• Maintain validation documentation and support GMP audits/inspections

About you

• Diploma/Degree in Engineering, IT, Computer Science, Life Sciences, Quality or related discipline
• Strong experience in Computer System Validation (CSV) within a GMP/GxP environment
• Hands-on experience preparing/reviewing URS, FDS, SDS, HDS, DQ, IQ and OQ documentation
• Experience in Data Process Mapping, Data Vulnerability Assessment and Data Integrity
• Familiar with validation testing, traceability, deviation handling and change control
• Knowledge of GMP/GxP and computerized system compliance
• Experience with Cytiva UNICORN, Telstar LyoSuite or similar manufacturing/laboratory computerized systems will be advantageous
• Good documentation and stakeholder management skills

GMP Technologies (S) Pte Ltd | EA License: 11C3793 | EA Personnel: Dianna| Registration No: R1327268

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We regret that only shortlisted candidates will be notified.