Anuranjan Saroj

WORK HISTORY

EDUCATION

SKILLS

ABOUT ANURANJAN SAROJ

Currently I\'m in Sparta System, a Honeywell Company. It\'s product (software) based company for Quality Management solutions in pharmaceutical & medical devices company. I am working as Expert Product Manager. Functional Background; A pharmaceutical professional having reach experience in Quality Management system, validation & qualification (CSV, CSVc & Automations). I’m having exposer of implementing many QMS software\'s i.e, SAP, LIMS, LES, Track-wise, Schedule Manager, Document management system, Learning management system, BMS etc. e-compliance and monitoring. Perform Quality System reviews related to the System Life Cycle documentation and Change Control that ensures consistency to Quality systems. Quality review and writing of Standard Operating Procedures, Qualification Protocols i.e. IQ, OQ, PQ and Global Templates for computer system validation as well and other GMP environment equipment/instruments. Ensure proper Risk assessment of software\'s to ensure the compliance of regulatory requirements. Periodic review and GAP assessment of critical GxP computerized systems to ensure the compliance of regulatory requirements. To Write guidelines, procedures, URS and approved FRS, DDS, IQ, OQ, traceability matrix and Validation Summary Reports. Provide technical support, and regulations and standards support to the audit team.