Sharmiti Karambelkar

Detail-oriented and highly motivated B.Pharm graduate seeking an entry-level position as a Junior Regulatory Executive. Eager to leverage foundational knowledge of ICH guidelines, CTD/eCTD dossier structures, and data integrity alongside practical exposure to API manufacturing documentation at Aarti Drugs Ltd. and an Elite NPTEL certification in Clinical Trials. Committed to ensuring strict corporate compliance, precise data formatting, and regulatory excellence.

Internship Trainee - Aarti Drugs Ltd. - Boisar, Maharashtra

(2024-05 - 2024-06)

• Industrial Familiarization: Completed a structured industrial training program across key manufacturing and operational departments, including Quality Assurance (QA), Quality Control (QC), and Production.
• Documentation & Compliance: Assisted in reviewing and organizing Master Formula Records (MFR), Batch Manufacturing Records (BMR), and Standard Operating Procedures (SOPs) to maintain strict compliance with cGMP standards.
• Analytical Exposure: Observed data collection methods, instrument calibration protocols, and sample testing procedures using analytical instruments like HPLC, UV-Spectrophotometer, and dissolution apparatus.
• Regulatory Alignment: Gained hands-on experience in cross-verifying raw operational data with corporate compliance checklists, building a solid foundation in data integrity.
• Workflow Optimization: Shadowed senior executives to understand the end-to-end workflow of API manufacturing, raw material inspection, and final product release documentation.

Bachelor of Pharmacy - B.Pharm - SSR College of Pharmacy, Silvassa (2026)

Higher Secondary - HSC - Aldel Education Trust's St. John Junior College, Palghar (2021)

Secondary School - SSC - Mehernosh Boman Burjor Irani Educational Academy (2019)