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The Testing & Computer System Validation Specialist role involves ensuring compliance with regulatory standards in the Healthcare sector. Candidates should have 5-8 years of experience in Computer System Validation, particularly in IQ, OQ, and PQ activities. A bachelor's degree in Engineering, Computer Science, or Life Sciences is required. Strong documentation and analytical skills are essential for success in this position.
Job Responsibility:
Plan, execute, and document Computer System Validation (CSV) activities in compliance with regulatory requirements (GxP, FDA, EMA, etc.)
Develop and review validation deliverables including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, and Validation Summary Reports
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems
Execute manual and automated testing activities aligned with validation requirements
Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles (ALCOA+)
Collaborate with cross-functional teams including Quality, IT, Business, and Vendors
Support audits and inspections by preparing validation evidence and responding to audit queries
Participate in change control, deviation management, CAPA, and periodic reviews of validated systems
Provide guidance and mentorship to junior validation/test team members as needed
Requirements:
5–8 years of hands-on experience in Testing and Computer System Validation within the Healthcare / Life Sciences domain
5+ years of strong practical experience with IQ, OQ, and PQ execution
5+ years of in-depth knowledge of CSV methodologies and regulatory standards (FDA, GxP, GAMP 5)
5+ years of experience validating systems such as LIMS, QMS, ERP, EMR, or Clinical systems is a plus
Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
Nice to have:
Solid understanding of SDLC, STLC, and risk-based validation approaches
Exposure to automation testing tools or test management tools is an added advantage
Prior experience working in regulated environments with global clients