Yogesh Bhole
IT Infrastructure & Cybersecurity | GxP/CSV Compliance Lead
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About
Strategic IT Leader with 13+ years of experience driving infrastructure reliability and regulatory compliance in FDA/GxP-regulated pharmaceutical manufacturing. Proven track record of delivering 99.9% system uptime and leading zero-observation regulatory inspections through rigorous Computer System Validation (CSV) and cybersecurity controls. Expert in bridging the gap between IT/OT security and Quality Assurance, ensuring 21 CFR Part 11 compliance across laboratory and SCADA environments.
Experience
Deputy Manager - Information Technology - M J Biopharm Pvt. Ltd.
(2017-02)
- Architected and deployed a multi-layer security stack (Sophos Firewall, CrowdStrike EDR, Trellix) across production sites, reducing the Mean Time to Detect (MTTD) threats by 40% through coordinated SOC/SIEM monitoring.
- Owned the end-to-end validation lifecycle (IQ/OQ/PQ) for critical lab systems (Empower HPLC, Shimadzu) and SCADA (Rockwell/Siemens), ensuring 100% compliance with GAMP 5 and 21 CFR Part 11 across 50+ validated workstations.
- Authored and maintained SOPs, Validation Master Plans (VMPs), and Change Controls, directly contributing to zero observations during multiple regulatory and customer audits.
- Maintained 99.9% uptime across corporate and production networks by implementing proactive monitoring and leading root-cause analysis for critical incidents.
- Designed and executed a NAS-based Backup and Bare Metal Recovery (BMR) strategy, successfully meeting defined RTO/RPO targets through rigorous quarterly DR drills.
- Managed SLAs, negotiated contracts, and oversaw IT procurement for biometric access control and telephony, reducing annual vendor costs by 15%.
Engineer, L2 Infrastructure Support - VAJ IT Consulting Pvt. Ltd.
(2014-06 - 2016-10)
- Resolved complex Windows Server and application incidents for enterprise clients, consistently surpassing SLA resolution targets.
- Administered Active Directory, Group Policies (GPO), and LAN/WAN segmentation to enforce least-privilege access and secure network perimeters.
System Engineer, L1 Support - Lumax Automotive Systems Ltd.
(2011-06 - 2014-05)
- Provided IT support to 200+ manufacturing and corporate users, managing hardware/software troubleshooting and full asset lifecycle management.
- Standardized IT infrastructure deployment, reducing recurring support tickets by 25%.
Education
Bachelor of Arts - B.A. - Tilak Maharashtra University
Hardware & Networking Certification - Jetking
