Veeresh Hiremath Email & Phone Number

Experience in working with pharmaceutical industry; life sciences domain, computerized system validation, ensuring quality & compliance. Specialized in validating software systems to meet regulatory requirements such as FDA, 21 CFR part 11 and GAMP 5 Guidelines.  Experience in reviewing validation deliverables as per Life sciences compliance and GDP standards. Ensuring all project-related risks are well managed and deliverables are validated (for GxP) in accordance with SOP and CSV requirements. Possess experience in performing Periodic Review Assessments for the IT GxP systems to ensure that computer system remains compliant with regulation, is fit for its intended use and satisfies company policies and procedures. Experience in reviewing all SDLC documents, protocols, and SOPs to ensure they meet GxPand FDA regulations. Perform System Risk Assessments and review action plans to ensure compliance during and after validation. Review of Change controls, incidents, problems and ensuring RCA has been conducted and implemented. Establishing and implementing corrective and preventive actions (CAPAs) and process improvements initiatives for CSV projects. Reviewing requirements, Specifications and technical design documents to provide timely and meaningful feedback on the gaps.• Good knowledge on 21CFR Part 11, GAMP 5 and EU Annex 11.