Atul Raut

About Atul Raut

Senior Associate at PwC with expertise in SaaS validation, SAP S/4HANA data migration…

Experience

1. Senior Associate

   PwC

   Jan 2024 — Present · Mumbai, IN

   Performed review of validation dossiers for compliance w.r.t 21 CFR part 11 requirements wherever applicable and GAMP5 principles- Review procedures mentioned in the operational SOPs and organizational password policy, identifies gaps and provided a gap assessment report along with the risk impact assessment- Prepared remediation plan to address gaps and eliminate/mitigate the risks- Performed validation as per 21 CFR part 11, EU Annex 11 and GxP compliance- Experience working with multiple IT solutions for ISMS ISO 27001 Implementation, Audits and assisting clients in remediation of identified gaps and observations using ISMS controls- Complete User management review (Privilege matrix, Roles, Authorization forms (active and disabled user), list of active users, SOD conflicts, Group Management, Vendor access, common login credentials Password policy etc.)- Demonstrated meticulous traceability, showcasing the alignment of requirements and specifications throughout the execution phase- Performed gap assessment of standard operating procedures of client’s computer systems both on-premises systems and cloud-based systems- Prepared Business continuity plan and disaster recovery procedures- Experience in securing applications and infrastructure, identifying vulnerabilities, developing exploit code- Experience in driving QMS activities such as change controls, authoring, reviewing deviations and CAPA records- Worked closely with Vendor, IT and Business teams to ensure adherence to IT QMS.

Education

• Govt. Sardar Vallabh Bhai Patel Polytechnic College Bhopal

  Diploma

  2011 — 2014

• N.R. I Institute of Research & Technology, Bhopal

  Rajiv gandhi prodhyogiki vishvavidhyalaya Bhopal

  2015 — 2018