Ayan Mondal — Consultant

A driven, committed, and resilient person who always believes in 3P : Positivity, Practicality and Potentiality. An adaptive learner who likes to explore new things and upgrade consistently. An MBA graduate from IIM Visakhapatnam, worked as Validation Analyst for 2.7 years with hands on experience in the following domain : • Validating computer systems deployed in Life Science domain • Primarily responsible for the creation of FRS, FRA, IQ Scripts, OQ Scripts, Test Deviation Report, TRM and performing activities like adhoc, dry run, execution of IQ and OQ, review of execution log and OQ/PQ specification documents, 21 CFR assessment, SOP Drafting, regression testing, finding bugs, testing fixes, providing suggestion from QA perspective etc. • Trained in Waterfall and Agile method of Validation • Experienced handling Indian customers (requirement gathering and analysis, resolution etc.) • Acquired knowledge on SDLC, CSV concepts, guidelines and regulations on GxP such as 21 CFR Part 58, ICH GCP, 21 CFR Part 11, EU Annex 11 and Japanese ERES • Authored and maintained well-organized, efficient and successful manual test cases and documented the test result for future evidence and thus prepared the major deliverables • Demonstrated leadership skills in managing projects from concept to completion Passionate to know about Food science and Agri-business Management

Stackforce AI infers this person is a Validation Specialist in the Life Sciences industry.

Location: Bengaluru, Karnataka, India

Experience: 3 yrs 11 mos