Chethankumar S C Email & Phone Number

Achievement-driven Quality Professional with 8 years of experience in pharmaceutical Manufacturing OSD, Sterile Product and qualification and Validations of Softwares and Analytical instruments, Quality Assurance & Compliance with a growth-oriented organization. Knowledge on V-model of validation for GxP Projects for Life science, pharmaceutical and healthcare industry.Developing, Reviewing, Validating and Monitoring of Test scripts, Test plans & Test cases based on URS from clients. Effective handling of OOS, OOT, Incidence and non-conformance occurred during validation and audits. Expertise in Preparation of Validation Plan and protocol, Validation Report, RTM & SOP writing and revision. Abilities in Data management & validating various quality documents using software’s in pharmaceutical companies.Responsible for Testing and verification of Validation for Laboratory instruments on GAMP guidelines.Exposure to GxP, GAMP, USFDA, EU guidelines, 21CFR Part 11, EU Annexure 11 for Pharmaceuticals and Software as medical Devices industry.