Sonakshi Sharma Email & Phone Number

Toronto, Canada Area

Mumbai Area, India

Worked as a Business Lead, with additional responsibilities including office administration, stock keeping and team management.Excelled in managing relations with key retailers and other stock holders.Attracted a large number of clients, by managing large complicated bulk orders within record time.Improved profitability significantly by improving process efficiency and reducing process wastage.

Bangalore

-Performed analytical tests and conducted compliance verification to evaluate effectiveness and qualityof various drugs, and to ensure compliance with the requirements of the respective regulatory agencies-Conducted online testing and assisted the supervisor in documents review for applicable sample -Executed physical sampling and testing to investigate samples for corrective and preventive actions (CAPA), Reported any deviation in the result of running batch to the supervisor for immediate corrective actions-Extensive use of Infrared/Ultraviolet Spectroscopy, High-Pressure Liquid Chromatography (HPLC) and various other analytical tools; Ensured calibration and maintenance of the equipment as per SOP-Aided with administrative tasks relating to data entry, review of documents and test results-Assists in audit preparation and provision of documents to auditors-Aided with regulatory preparation documents in accordance with relevant guidelines and SOPs-Collaborated with internal departments like manufacturing, marketing, and clinical research for Regulatory assistance on various product portfolio-Assisted in preparation and submission of the dossier and summarized technical information for regulatory submission in markets like EMA and US FDA-Assisted supervisors in assembling data related to regulatory submissions to regulatory authorities like EMA and FDA-Ensured Quality operations are performed in accordance with GMP guidelines, regulatory requirements and company’s policy

Bangalore

Worked with some of the industry expert and worked in area of Molecular Biology and Recombinant DNA Technology

Post Graduate Certificate In Regulatory Affairs, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs

Canadian Food and Drugs Acts and Regulations and Guidelines. Managment of Global Regulatory Submission Knowledge Of FDA, EU, and Global.

Bachelor’S Degree- Evaluated By Wes, Biotechnology

Excelled in all technical subjects with exemplary grades.

High School