Rohan Aditya — Associate Consultant

• 7+ years of extensive experience in computer system testing and validation, Medical Devices verification & validation in Pharmaceutical/ Life Sciences domain. • Good understanding of GxP standards, GAMP 5 categories, 21 CFR Part 11 & Part 820, EU Annex 11, HIPAA compliance • Hands on experience in performing IQ, OQ, UAT and PQ for computerized systems and medical devices. • Highly experienced in authoring and reviewing the validation documentation such as Validation Plan (VP), Validation Summary Report (VSR), Changes Request Form (CRF), Change Implementation Plan (CIP), Change Implementation Report (CIR), Test Protocols. • Extensive Experience in testing and validation of applications based on various platforms such as Windows, Android iOS. - EY Certified Life Science Bronze

Stackforce AI infers this person is a Healthcare Compliance Specialist with extensive experience in validation and regulatory frameworks.

Location: Pune, Maharashtra, India

Experience: 7 yrs 6 mos