Application Development Senior Analyst
Accenture - India
Total years of experience :8 years, 9 Months
• Currently working on QMS system for one of the leading Pharma company.
• Document Review.
• Risk Assessment.
• In hand experience of the System Development Life
Cycle (SDLC).
• In hand experience in Polarion ALM and Valgenesis
documentation.
IVY Works provides consulting, development and support services related to compliance, validation, IT, computer systems, and software applications to clients in the life sciences industries.
➢Leading a Team size of 6 employee on client location.
➢ Preparation, Review and Execution of all deliverables (URS, VP, DS, RA, IQ, OPQ, TM and VSR) for PLC-HMI/SCADA based Equipment.
➢ To Evaluate the discrepancies that is observed during qualification and proposed the CAPA actions and Implementing and ensuring 21 CFR Part 11 compliance.
Data Collection from the Lab Instrument and Manufacturing System.
• Document Preparation (V-model) for the PLC-HMI/SCADA based equipment and Lab
Instruments and Execution of IQ and OQ
,