Role Descriptions: Computer System ValidationPlan| execute| and maintain validation activities for GxP relevant computerized systems in accordance with regulatory and internal quality requirements Develop and review validation deliverables including Validation Plans| User Requirements| Risk Assessments| Test Protocols| Test Scripts| Traceability Matrices| and Validation Summary ReportsEnsure validation activities demonstrate that systems are fit for intended use| reliable| and operate in a controlled environmentRisk Based Approach & ComplianceApply risk based validation principles aligned with regulatory expectations (e.g.| GxP| Part 11| ISO 13485) Support audits and inspections by providing explicit| complete| and compliant validation documentationAssess impact of system changes and support re validation activities as requiredChange & Configuration ManagementEnsure validated systems remain in a compliant state through effective change control and configuration management Review system updates| patches| and enhancements to determine validation impactMaintain system inventory and validation status throughout system lifecycleCross Functional CollaborationWork closely with IT| Quality| Engineering| Vendors| and Business stakeholders to support validation activitiesParticipate in system implementation projects to embed validation from early lifecycle stagesSupport training and awareness on CSV processes and regulatory expectations________________________________________________________________________________Preferred Skills & ExperienceIn-depth understanding of Computer System Validation (CSV) and Computer Software Assurance (CSA).Understanding SDLC and its various phases/ stages.Understanding and Expertise in Risk Management (ICH Q9 and ICH Q8).Understanding of GAMP categories.Understanding of Industry Standards like ISO 13485Understanding on QMS and regulations like 21 CFR Part 820Understand GSM (SDLC) methodology and different procedures to implement it.Understanding and implementation expertise of CSV deliverables.Provide consultations to project teams on how to implement validation as appropriate for the selected S/W Validation approach.Recommend project teams which validation approach might be more suitable for them.Understand SOP and Work Instructions and guide project teams on how to create deliverables.Understand Regulatory compliance like PI/ PHI| ERES (21 CFR Part 11) to the extent to provide consultation when requiredExpertise on change management process and Provide consultation to implement Software changes.Review and Approve Validation deliverables and System changes.
Essential Skills: Computer System Validation (CSV) Specialist / Analyst
Desirable Skills:
Keyword:
Skills: Life Sciences : Computer System Validation
Experience Required: 6-8

Location: GG V - Bldg6-4A SEZ~Global Axis H Block~TCS Ganga NSTP

📌 Computer System Validation Engineer (Bengaluru)
🏢 Cerebra
📍 Bengaluru