A Subject Matter Expert, Experienced IT Compliance Leader, Auditor and Trainer with more than 2 decades of specialized, extensive, qualitative and diversified experience in pharmaceuticals, healthcare, clinical research, life sciences, medical devices and software compliance domain. Having wide hands on experience in Data Integrity, CSV, CSA, cGxP, GAMP, GDPR, 21 CFR Part 11, 21 CFR Part 820, EU Annex 11, ISO-QMS, ISO-13485, ISMS and other global standards, regulations, compliance requirements and adherence.Specialist in both core and compliance field including complied infrastructure services as per global standards, compliance audits, gap analysis, risk & quality management, data integrity, CSV, CSA, Validations, Data Backup & Security, e-Archiving, Disaster Planning, Process Excellence and other global compliance. PROFESSIONAL SNAPSHOT :Having strong technical background to plan, design, establish, manage and maintain Core & Compliance processes with data integrity requirements.In-depth knowledge of compliance, data integrity, design verification, various validations, audits, risk management, data security, interfacing, automation, software designing/development and connectivity to ensure safer, secure, smooth and seamless processes/operations. Providing assurance and advisory services to organizations looking to implement or expand on their internal controls in an effort to meet current industry standards set forth by various regulations and regulatory agencies for proper compliance framework. Extensive experience with proven ability in managing multi domain, multi technology, large projects with risk identification & mitigation and analyzing critical business requirements.Offers customized training programs, refresher trainings, best practices workshops to create and facilitate Any Time Audit Ready culture.Successful planning, designing and implementation of overall 18+ national as well as global IT Setups.

Function as Global IT head to manage and maintain total IT setup of Cliantha Research Limited. Mainly responsible for evaluate, monitor and enhance IT infrastructure with an emphasis on availability, reliability, scalability, security, data confidentiality and system integrity. Led the charge to overhaul IT setup of 9+ national as well as global IT setup of company starting from due diligence till final implementation including designing, budgeting, planning, procurement, installation, implementation, centralization, network, servers, security, virtualization, desktop, backup system, software and complete remote connectivity/access.Successfully contributed as Global IT Head in 50+ regulatory and 150+ clients/sponsor inspections/audits (without any major observation/483s) held at local as well as global locations of the company.Responsible to ensure efficient and effective IT processes- IT infrastructure, electronic data automation, backup, disaster recovery, electronic data archiving, risk assessment and mitigation, time management, best practices and IT SOPs for preserving the integrity and security of data, reports and access.Many more....

Worked as a full-time service engineer to handle and maintain company’s various contractual sites to manage IT hardware, software, network and printers for minimal down time. Provided total IT support to government, private and MNC clients of company including network, connectivity, troubleshooting and proper accessibility of IT infrastructure.

Worked as a full-time system executive to handle and manage IT setup and software of company. Provided IT support to all the applicable branches for smooth and error free data transmission.

Worked as a full-time system executive to handle, manage and develop FoxPro and Clipper based Construction Project Management Software. Also managed Novell NetWare servers and other IT infrastructure of the company.