Role & responsibilities: Developing Validation Documentation and support for computerized systems used in GLP, GMP and GCP environments. (Manufacturing and Laboratory Systems) Developing Validation Documents and Execution of Validation Protocols. Validation Documentation will encompass validation plans, specifications, test protocols and standard operation procedures. Systems include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure. Preferred candidate profile Candidates must have experience/exposure to Computerized System Validation (CSV) especially PLC Validation 21 CFR Part 11, EU Annex 11 and GAMP 5. Good communication and technical writing skills are a must. Candidate should be ready to travel within Gujarat.