P.VASANTHI M. Pharm., (MBA)

Motivated individual with a strong background in laboratory research and quality assurance. Proficient in time management and organization, excels in diverse settings. Diligent project management specialist successfully plans,develops and implement projects.

• Lead investigator in OOS, Change control, Lab investigation and Deviation
• Qualified reviewer
• Experienced in conducting sessions related to projects.
• Contributed in preparation of regulatory (32p83a) to health authorities.
• Mentored new employees in software's
• Supported in GCA, FDA audits as Scribe, Runner and reviewer.
• Expert in preparing SOPs, working instruction and stability protocol.
• Performed Analysis, Qualification, development, Method transfer, Calibration and Validation activities
• Supported in Analytical lab setup during Novartis Mumbai OTC to Hyderabad.

Masters in Pharmaceutical Analysis

Lean Six Sigma

[MBA (in progress)]

Received Mentorship from GSK-QA department for about 2 years to learn about QA activities, investigations, CAPA, Deviations, Change control, supporting internal audits.

• Global Corporate Certification training as a 'Lead investigator for Lab Investigations' (88%) from Novartis.
• Lean Six Sigma Green Belt and Yellow belt certification course from Benchmark Six Sigma.
• Certified in Presentation fundamentals
• Certified in MS-Office-XP
• Certified Lifesaver Fire saver and emergency preparedness
• Certified in Power Business intelligence(BI)
• Certified in Structured query language (SQL)
• Certified in Data Visualization using Tableau

• Received Appreciation award for the Preparation of Global SOP of Manual Integration Guidance.
• Received Above and Beyond Award for the Project ownership of Syrups and Gels in Novartis Healthcare Pvt ltd.
• Received Global Employee Recognition Appreciation Award for 'Excellent execution of Pain category project, generation of 3 months stability report and CMC documents by demonstrating work across boundary and drive performance' in GSK.

• Waters AcQuity UPLC (Ultra performance liquid chromatography)
• Waters Alliance HPLC (high performance liquid chromatography)
• Agilent 1200 DAD HPLC
• Shimadzu LC-20 HPLC
• Shimadzu LC-10 AT HPLC
• CAMAG HPTLC
• Spectrofluroimetry (Jasco)
• JASCO & Shimadzu UV-Visible Spectrophotometer
• Jasco & Shimadzu FT-IR Spectrometry
• Dissolution Apparatus - Electro lab, Lab India and Erweka
• Disintegration Apparatus
• KF Titrator - Metrohm
• Potentiometer - Metrohm
• Viscometer and hardness tester
• LOD Moisture Balance, Water activity meter and Halogen Moisture analysis
• Titrimetric analysis

• GLIMS
• CLS
• Diga
• Empower 3
• Phoenix (regulatory)

• English
• Tamil
• Hindi (Certified)

I hereby declare that the above-furnished details are true to the best of my knowledge and belief.