Kashish Jain

Performed routine and non-routine QC testing and cell/microbiology handling in a GMP environment, maintaining 100% cGMP/GDP compliance and reducing repeat deviations by 18% through CAPA and investigation leadership.

Led regulatory activities for global medical and life-science products, ensuring 100% compliance with FDA, EU MDR and UKCA requirements and achieving zero critical audit findings; reduced repeat compliance issues by 18% and cut overdue actions by 22%.

Supported GMP QC operations including environmental monitoring, deviations/CAPA and change control, maintained LIMS and documentation to ensure data integrity and 100% on-time reporting for audits.

Supported pharmaceutical quality and regulatory activities under cGMP/ICH/ISO, maintained deviation and CAPA trackers with 100% on-time closure and improved documentation efficiency by 10%.

Assisted with QC microbiology testing, aseptic processing and data integrity checks under GMP/GLP, maintained laboratory records and supported investigations and validation activities.

Supported QC and regulatory documentation in GMP/GLP environments, assisted with equipment logs, controlled documents, and compliance checks while contributing to investigations and risk assessments.

Master of Science in Biotechnology and Management program at the University of Glasgow from September 2023 to September 2024.

Completed a Bachelor of Science (Hons) in Biotechnology with laboratory-focused coursework and practical training in molecular and microbiological techniques.

Bachelor of Science (Hons) in Biotechnology completed at Amity University, Lucknow from September 2020 to May 2023.

Completed a Bachelor of Science (Hons) in Biotechnology with coursework and practical experience in molecular biology and bioprocess techniques.