Computer System Validation (CSV/CSA)

Role & responsibilities

Execute CSV/CSA activities for the implementation, validation, and lifecycle management of the RIM system. •Ensure validation activities are performed in accordance with GxP requirements, 21 CFR Part 11, EU Annex 11, GAMP 5 principles, and organization-level validation procedures. •Prepare, review, and execute validation deliverables such as validation plans, risk assessments, requirements traceability matrices, test protocols, test scripts, test summary reports, and validation summary reports. •Support risk-based validation and CSA approaches by identifying critical business processes, system risks, data integrity risks, and compliance controls. •Validate RIM modules including Correspondence, Commitments, Publisher, Paper Dossier, Validation, Viewer, Registration, and Tracking modules. •Support validation of RIM business processes used for healthcare regulatory operations, including Pharmaceutical and Medical Device business areas. •Review system requirements, functional specifications, configuration documents, interface specifications, and business process documentation from a validation and compliance perspective. •Support data migration validation activities, including migration strategy review, data mapping verification, data reconciliation, migration testing, and evidence review. •Support validation of SAP integration with the RIM system, including interface testing, data flow verification, error handling, and compliance evidence review. •Collaborate with Regulatory Affairs, Quality Assurance, IT, business SMEs, vendors, and implementation partners to ensure validation deliverables are complete, accurate, and audit-ready. •Identify, document, track, and support closure of validation defects, deviations, risks, and open issues. •Ensure compliance with electronic records, electronic signatures, audit trails, access controls, data integrity, and security requirements. •Support change control, periodic review, audit readiness, and inspection support activities for the validated RIM system. Required Skills and Experience •Strong hands-on experience in CSV and CSA activities for GxP-regulated computerized systems. •Good understanding of regulatory requirements including GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles, and validation lifecycle expectations. •Experience in validation documentation preparation, review, execution, and approval. •Strong RIM business process knowledge, preferably across regulatory submissions, registrations, correspondence, commitments, publishing, tracking, and dossier management. •Experience supporting RIM system implementation, upgrade, enhancement, or migration projects. •Hands-on experience in data migration validation, including source-to-target mapping, migration testing, reconciliation, and defect management. •Experience with SAP integration validation or validation of system interfaces between enterprise applications. •Ability to understand business requirements, system configuration, workflows, data flows, and compliance impact. •Strong knowledge of audit trail, electronic signature, access control, security, and data integrity validation requirements. •Excellent documentation, analytical, communication, and stakeholder management skills. Education and Qualifications •Bachelors or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, Information Technology, Engineering, or a related discipline. •Relevant experience in healthcare, pharmaceutical, biotechnology, medical device, or other regulated life sciences environments. •Certification or training in CSV, CSA, GAMP 5, data integrity, or regulatory compliance will be an added advantage. Preferred Experience •Prior experience with RIM platforms used for global regulatory operations. •Experience supporting both Pharmaceutical and Medical Device regulatory processes. •Experience working in cross-functional global project teams involving Quality, Regulatory, IT, business, and vendor stakeholders. •Experience supporting audits, inspections, validation remediation, and compliance gap assessments. Ideal Candidate Profile The ideal candidate should be a strong CSV/CSA professional with practical RIM business knowledge and hands-on experience in data migration and SAP integration validation within a healthcare or regulated life sciences environment. Job Description: CSV/CSA and RIM Validation Specialist Key Responsibilities •Execute CSV/CSA activities for the implementation, validation, and lifecycle management of the RIM system. •Ensure validation activities are performed in accordance with GxP requirements, 21 CFR Part 11, EU Annex 11, GAMP 5 principles, and organization-level validation procedures. •Prepare, review, and execute validation deliverables such as validation plans, risk assessments, requirements traceability matrices, test protocols, test scripts, test summary reports, and validation summary reports. •Support risk-based validation and CSA approaches by identifying critical business processes, system risks, data integrity risks, and compliance controls. •Validate RIM modules including Correspondence, Commitments, Publisher, Paper Dossier, Validation, Viewer, Registration, and Tracking modules. •Support validation of RIM business processes used for healthcare regulatory operations, including Pharmaceutical and Medical Device business areas. •Review system requirements, functional specifications, configuration documents, interface specifications, and business process documentation from a validation and compliance perspective. •Support data migration validation activities, including migration strategy review, data mapping verification, data reconciliation, migration testing, and evidence review. •Support validation of SAP integration with the RIM system, including interface testing, data flow verification, error handling, and compliance evidence review. •Collaborate with Regulatory Affairs, Quality Assurance, IT, business SMEs, vendors, and implementation partners to ensure validation deliverables are complete, accurate, and audit-ready. •Identify, document, track, and support closure of validation defects, deviations, risks, and open issues. •Ensure compliance with electronic records, electronic signatures, audit trails, access controls, data integrity, and security requirements. •Support change control, periodic review, audit readiness, and inspection support activities for the validated RIM system. Required Skills and Experience •Strong hands-on experience in CSV and CSA activities for GxP-regulated computerized systems. •Good understanding of regulatory requirements including GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles, and validation lifecycle expectations. •Experience in validation documentation preparation, review, execution, and approval. •Strong RIM business process knowledge, preferably across regulatory submissions, registrations, correspondence, commitments, publishing, tracking, and dossier management. •Experience supporting RIM system implementation, upgrade, enhancement, or migration projects.