Yogesh Bhole

Having a diversified experience and sound knowledge in Server and Network.. Computer system validation. 21 CFR part 11 compliance, data Integrity. Good knowledge about cGMP requirements, GAMP5. Hands on experience of IT related Hardware, networking, desktop, laptop and server group policies issues Application know-how of Biotech Process equipment, Utility system, QC Laboratory equipment, Process development lab. Expertise in handling and troubleshooting of HPLC and TOC software (Empower2/3, Open Lab, and TOCL etc.)

• Graduation
• Hardware and Networking Diploma

• Installation and Configuration of Servers, Switches, Antivirus, Routers and Access Points)
• Managing User Accounts, Projects, Audit trial, Message Center, Backup & Restore in HPLC, UV, Rockwell and other systems
• SOP Preparation for IT related system used in organization
• Troubleshoot EPBX system
• Ensuring resource availability and allocation. Ensure that all IT activities are delivered on-time-in-full, within scope
• Coordinating internal resources and third parties/vendors for the flawless execution of projects
• Create and maintain comprehensive Information documentation include SOP, Risk Assessment, change control register, activity list, risk register, issue log, and other similar documents
• Manage the relationship with the vendors
• Performed CSV for Empower 3 server and client software
• Department Lead – Information Technologies in WHO GMP certified biotech plant
• Involved and faced WHO, FDA & customer specific audits
• Perform risk management to minimize/mitigate the system risks

• Date of Birth: 01/28/86
• Gender: Male