* Quality Management system Expertise : clinical & regulatory : (Veeva quality Vault, enterprise quality vault and TrackWise)* Document Control: * Proficient in document control processes, ensuring compliance with regulatory standards and internal policies.* Standard Operating Procedures (SOP): * Expertise in reviewing and developing SOPs to enhance operational efficiency and ensure adherence to best practices.* Deviation and Change Control: * Skilled in managing deviations and change control processes, effectively mitigating risks and ensuring quality assurance.* Quality Risk Management: * Extensive experience in quality risk management, applying proactive strategies to identify and address potential quality issues.* Audit Experience: * Faced internal and external audits and conducted * Data Trend Analysis: * Conducted data trend analysis utilizing Operational Metrics Repository, enhancing data integrity and quality checks.* Training and Development: * Developed and delivered training programs for staff on quality management practices and compliance requirements.* Cross-Functional Collaboration: * Collaborated with cross-functional teams to align quality objectives with organizational goals, fostering a culture of quality.* Process Improvement Initiatives: * Led process improvement initiatives that resulted in enhanced efficiency and reduced operational costs.

-Expertise in handling QMS elements: Deviations, OOS and OOT, Change controls, assisting in CAPA implementation --Handled continuous process monitoring --Review & Approval of BMR, PDR, SOP, study protocol & reports, MFR, APQR, validation protocol and reports, TTDs, Qualification reports of instruments, etc. -Assessment of IPQA-related change controls to assure proper impact assessment to develop and maintain quality--Provide support to enhance the efficiency of internal audits, and identify key improvement areas. -Proficient in Risk management systems, Process Validations - monitored shop floor activities, reported, non-compliance in terms of deviations, or any incident that may have a direct adverse effect on the quality of a product, system, and facility.-Create, review and approve Good Manufacturing Practices audit reports and provide feedback and guidance on corrective and preventive actions. -Provided cGMP & SOP trainings -Review and compilation of documents required for dossier filing to regulatory bodies and addressing queries on old/new submissions -Ensured line clearance during manufacturing & packing and provided inputs for sampling and dispatch activities. -Been an active part in the management of Regulatory audits: USFDA, EMA, CDSCO, TGA, ANVISA, and Customer audits and ensured minimal observations

1. Analytical data review and approval of Drug Substance (Stability & Finished product DS)a. Stability Management through Nova-LIMS. Batch release through SAP. b. Compiling and providing the data for regulatory submissions and providing support, addressing queries for existing or new submissions.c. Review, approval and submission of developmental, clinical, process validation and annual stability data.2. Preparation and review of Product quality review 3. Preparation and establishment of OOT trend limits4. Review and approval of Non-routine documents5. Review and approval of excel Templates validations6. Review and approval of Analytical method validations & method transfers.7. Review and approval of Laboratory incidents8. Handled QMS :OOT, Deviations, change controls, CAPA implementation (Trackwise)9. Review and approval of working standards and Internal reference standards.10. Review & approval of Specifications, STPs, SOPs, Study protocols, Study reports, etc...11. Participated in Regulatory & customer audits.

Biocon-KGI Certificate Program in Biosciences: - Bridges the gap between academics and biopharma industry.- 16 week full-time course designed to provide scientific background of the applications of Biotechnology.- The course dealt with concepts, applicat­ions, real scenarios ­on regulatory science­s, quality control, q­uality assurance, bio­-separations, ferment­ation principles, mol­ecular biotechnology,­ pharmaceutical devel­opment, mammalian cel­l culture, soft skill training and industrial visits - Class room trainings delivered by renowned Faculty from Keck Graduate Institute, California USA and Biocon AcademyPractical hands on training at Biocon facilities

MSc dissertation entitled as "Role of Enriched Environment on Hippocampal Pyramidal Neuronal Morphology in an Animal Model of Depression" : Evaluated the morphological changes in CA1 neurons in the hippocampus of the rat brain using "neonatal clomipramine model" to induce depression and treating it by the paradigm "Enriched Environment"