Hemant Dwibhashyam

About Hemant Dwibhashyam

Experienced Computer Systems Validation (CSV) professional with 3+ years of expertise in CSV and 7+ years in the pharmaceutical industry. Proficient in regulatory compliance (GxP, 21 CFR Part 11, EU Annex 11), validation processes, and data integrity principles. Skilled in authoring protocols, risk assessments, and conducting audits, with a track record of enhancing compliance and operational efficiency. Seeking to leverage advanced Computerized Systems Validation skills to drive quality and compliance in a dynamic organization.

Experience

1. Csv-qa Executive

   Bharat Biotech

   Feb 2023 — Present · Hyderabad, IN

   Led validation of automated systems (PLC/SCADA, HMI, lab instruments) to ensure regulatory compliance.2. Authored and reviewed validation protocols (IQ, OQ, PQ) and test scripts.3. Conducted functional risk assessments, system-level impact assessments, and gap analyses.4. Ensured compliance with 21 CFR Part 11 and EU Annex 11 for electronic records and signatures.5. Managed user access, privilege levels, and time synchronization for data integrity.6. Conducted internal audits and maintained CSV inventory.Key Achievements:1. Successfully validated critical systems, enhancing operational efficiency.2. mproved audit readiness by identifying and closing gaps in access control.

Education

• Sri Ramachandra University

  Bachelor’s Degree

  2006 — 2010

• Western University of Health Sciences

  Master of Science - MS

  2011 — 2012

• G. Pulla Reddy College Of Pharmacy

  Master's degree

  2013 — 2015