Nehal S.

Preparation of CSV documents • Preparation of IQ,OQ,DQ protocols and Execute • Implementation of Quality systems and procedures at sites related to QMS in alignment with corporate quality policies and global regulatory standards • Designing of work flow and electronic format for Risk assessment, CRF, deviation, Investigation and CAPA as per 21 CFR Compliance. • Expert in Packing Line issue (Alarm, Maintenance, Batch Flow) Experienced Validation Engineer skilled in U.S. Food and Drug Administration (FDA), Microsoft Excel, Customer Service, Microsoft Word, and Computer System Validation.