Sumeet Raina

Head of Compliance @Labforward

Berlin, DE

GDPR and cGxP Compliance.Creation, support and maintenance of Global QMS and ISMSLeading Computer System Validation (CSV) programs for SaaS/PaaS based systemsImplementation and review of security measures across the board including password manager tools, vulnerability detection, monitoringCertifications and Surveillance audits (Internal, external, ISO9001, ISO27001, othersInformation security risk assessment and mitigationsIT health checksConducting GxP, Risk, EU Annex 11, Data integrity, GDPR and 21 CFR Part 11 AssessmentsDeveloping CSV strategy for GxP systemsCreating the User and Functional Requirements specificationsAssuring that the system meets its requirements and compliance with SOPs, applicable client policies and procedures, and the requirements of Validation PlanCreating the Validation and Test strategyRisk based validation testing, reviewing and approving test executionsReviewing Validation Plan, Validation Strategy, Test Plan, Traceability Matrix and Validation/Test Summary ReportsAssisting in managing project and liaising between project tracks and client process owners to ensure that project is delivered on time and with qualityOverall Change ManagementInstrumental in standardization of processes and deliverablesExecution and management of internal audit programVendor and supplier auditsISO9001 external certification and surveillance auditsISO27001 external certification and surveillance auditsSPOC for customer and third party auditsSupport for regulatory audits

MIET

Bachelor of Engineering (B.E.)