Sushmita Ghosh

Drove deep compliance reviews against regulatory guidance and 483s, ensuring timely closure of identified gaps across plant, premises, processes, and practices. Supported the Unit Operations Leadership Team in driving time-bound closure of identified gaps and escalated critical issues to Unit Head for appropriate management attention.

Ensured investigation and deviation procedures were appropriately performed and documented, actively involved in Batch failure, OOS, OOT, and Stability OOS for root cause identification and CAPA implementation. Prepared and reviewed Quality trend reports for Deviation & CAPA, and coordinated, evaluated, and closed Deviation and CAPA requests through Trackwise.

Prepared documents for new products and regularization of old products, including MFC, QFR, and BMR summary reports. Handled OOS and OOT, preparing investigation reports, and raised deviations for products in case of process changes during processing.

Completed a Master of Pharmacy degree, focusing on advanced pharmaceutical studies and research. Gained in-depth knowledge of drug development, pharmacology, and pharmaceutical analysis.

Obtained a Bachelor of Pharmacy degree, covering fundamental aspects of pharmaceutical sciences. Developed a strong foundation in medicinal chemistry, pharmaceutics, and pharmacognosy.

Completed a Diploma in Pharmacy, acquiring essential skills for pharmaceutical practice. Focused on dispensing medications, patient counseling, and basic drug information.

Completed secondary education under the I.S.C. Board curriculum. Developed a strong academic foundation across various subjects.

Completed primary education under the I.C.S.E. curriculum. Gained foundational knowledge and skills in core academic areas.