Shiksha Batwal

Experienced CSV & CSA Expert with 12+ years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), SAP S/4HANA validation, risk assessment, and regulatory compliance for pharmaceutical, medical device, and semiconductor industries. Currently working as Deputy Manager at Deloitte India since June 2022, leading enterprise-wide SAP S/4HANA validation and compliance programs across regulated global markets. Expertise in validation of SAP modules including L2C, P2P, I2O, P2X, and QUM using SAP Solution Manager, Signavio process mapping, and JIRA-based project management within GAMP5 Agile methodology.

Strong knowledge of global regulatory standards including MDSAP, ISO 13485, 21 CFR Part 11, EU Annex 11, MDR 2017, China GMP, Taiwan GMP, ALCOA+, and Data Integrity requirements. Strategic leader and team coach with proven success in managing cross-functional global teams and delivering projects valued above USD 200 Million for clients (Zeiss) across Europe, USA, Latin America, and China.

Deputy Manager – CSV & CSA Expert - Deloitte India

(2022-06)

Leading Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for SAP S/4HANA enterprise systems across regulated medical device and semiconductor organizations.

• Performed end-to-end validation of SAP S/4HANA modules including L2C, P2P, I2O, P2X, and QUM through SAP Solution Manager.
• Managed process flow mapping and business process validation using Signavio tool for global transformation programs.
• Coordinated Agile project execution and validation tracking through JIRA for multiple global stakeholders and cross-functional teams.
• Prepared and reviewed risk assessments for critical SAP processes including delivery creation, sales from stock, invoice creation, and master data management.
• Ensured compliance with MDSAP, ISO 13485, 21 CFR Part 11, EU Annex 11, MDR 2017, China GMP, Taiwan GMP, and other global regulatory requirements.
• Acted as Team Leader and Coach for reporting team members by driving performance management, technical mentoring, and compliance awareness.
• Successfully managed and delivered validation projects exceeding USD 200 Million for clients across Europe, USA, Latin America, and China.
• Worked with global medical device and semiconductor clients operating in highly regulated markets under GAMP5 Agile and AI-enabled systems.
• Supported audit readiness, CAPA management, validation documentation review, and risk-based quality assurance initiatives.

CSV Consultant – Cyber Risk Advisory - Orcapod Consultancy (Deloitte Client)

(2021-09 - 2022-05)

Freelancer – CSV Documentation & Validation Reviewer

(2019-11 - 2021-08)

Sr. Executive - Cipla Ltd. - Goa

(2018-01 - 2019-11)

Sr. Associate - Mylan Laboratories Ltd. - Bangalore

(2014-04 - 2016-09)

Various Roles - Previous Companies

Job responsibilities in previous companies included:

• Preparation, review, execution and maintenance of Protocols like URS, DQ, IQ, OQ, PQ, RQ, Shutdown and other engineering/validation related documents as per CGMP, GAMP5, 21 CFR Part11, EU Annex 11, ISO 13485.
• Preparation, review and revision of Standard Operating Procedure of equipment/qualification related.
• Investigations of Equipment, Facility & Validation/Qualification, and operations related deviations.
• Handling of CAPA and change controls.
• Preparation, review and revision of Product/Process/Design Risk assessment (FMEA/FMECA) related to equipment/instrument/device.
• Access management/gap analysis as a part of Computer system validation program as equipment user.
• Responsible for managing, preparation/or reviewing documents required for development and validation of computerized system.
• Authors Validation Plan, Training Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test Incidents, Trace Matrix, RTM, Validation report and Summary Report.
• Overall CSV Compliance. CSV project and life cycle documentation, preparation, review and approval.
• Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description and Training records.
• Review & completion of permanent/temporary changes or planned deviations related to Introduction of new Equipment/software, Modification & Change in Facility/equipment/Device/software.
• Review of vendor validation documentation & coordinating the validation and troubleshooting activities.
• Management of different Software administration, audit trail review, back up and maintenance support along with IT team.
• Maintain up to date Software inventory.
• Initiation, review & completion of permanent/temporary changes or planned deviations related to Process/Procedure/Master document, Introduction of new Equipment, Modification & Change in Facility.
• Technical Trainer for Engineering Operations, Good Manufacturing Practices, Good Engineering Practices and Data integrity for computerized system.
• Ensuring compliance through review of audit trails, logbook, Alarm history, trends and user access level in different systems/Instrumentation like BMS, PLCs.
• Handling the QMS in Trackwise Version: 8.2 and 8.5.1.
• Handling and review of breakdown, work orders, calibration, maintenance, change/spare parts and machine history in SAP Version 7300.2.5.3278.
• Providing training to IT team & User by contributing knowledge and experience to help them to develop their compliance & technical skills, functional knowledge and quality awareness.

Master of Technology (M.Tech) - Power Electronics

Bachelor of Engineering (B.E.) - Electrical & Electronics Engineering