Ashish Kesharwani Email & Phone Number

✔ My success is due to the work of the teams I lead. As the African proverb says, "If you want to go fast, go alone; if you want to go far, go together." I bring this philosophy to my management style and empower my teams to be fully invested in our projects. By providing proper training, development, and mentorship, we're more productive as a unit. With a strong sense of ownership, my teams consistently ensure strong technical functionality in all of our projects, no matter how complex they are.Quality & Drug Regulatory Affairs, over 16 Years of Experience.𝑪𝒆𝒓𝒕𝒊𝒇𝒊𝒆𝒅 : Internal Auditor ISO 9001:2015 from BV.𝑪𝒆𝒓𝒕𝒊𝒇𝒊𝒆𝒅 : Computer System Validation & Computer Software Assurance from Blutech. 𝑲𝒆𝒚 𝑹𝒐𝒍𝒆𝒔 -1. Responsible for overall Quality Management System.2. Preparation and Maintenance of Procedure/Policy (SOPs).3. Responsible for overall Product Quality from Contract Manufacturing Organization. 4. Qualify Supplier by Site Audit as well as Quality Questionnaire.5. Audit Compliance of Contact Manufacturing Organization. 6. Experience on execution of Quality Technical Agreement. 7. Responsible for Tender Management activity.8. Hands on experience on Computer System like; TrackWise System, SABA, Documentum, COUPA.9. Also have worked on Dossier filling for ROW market, reviewing of QC & QA Documents. 10. Team Management.Connect with me to get the detailed exposure in the arena of quality management, manufacturer qualification, audits and regulatory affairs across pharmaceutical industries. Seeking to pursue a career in the upper echelons of an esteemed organization, that calls for extremely high levels of leadership qualities, technical abilities and regulatory knowledge and expertise with the goal of heading Quality Management functions to ensure quality standards and contribute to the success of the organization.

Listed skills include Pharmaceutical Industry, Regulatory Affairs, Sop, Gmp, and 7 others.