Venkat N

About Venkat N

Overall, five years of experience in Equipment Qualification in the pharmaceutical industry, where I have employed the \'V\' model and Life Cycle approach methodology. • Handling Process Equipment and Utility validations for pharmaceutical, biotech, and medical device industries. • Prepared and reviewed validation protocols, schedules, and PM schedules, and ensured compliance with Validation Protocols IQ/OQ/PQ documentation. • Experience in preparing and reviewing URS, DQ, FAT, SAT, IQ, OQ, PQ, and RQ Protocols, as well as conducting Risk Assessments, Decommission reports, and Periodic Review Reports. • Supported the gathering of requirements from Business users and reviewed the final URS to ensure compliance with 21 CFR Part 11 requirements. • Knowledge of GDP, GEP & GMP practices is proficient. I have handled discrepancies/defects identified during validation testing and proposed appropriate CAPAs for closure, and I have conducted review meetings with business and vendor teams to resolve open issues. • Handling CAPA and Non-Conformances, performing Gap analysis, and preparing Remediation Plans. • Possess excellent interpersonal, organizational, verbal, and written communication skills, and I am proficient in MS-Word, Excel, Power point, and Outlook application. • Having experience in LIMS like entry of a product and performing its tests required for the product.

Experience

1. Quality Control 2

   Cipla

   Feb 2025 — Present · NY, US

Education

• Jawaharlal Nehru Technological University

  Bachelor's degree