Kartik Gandhi MS,PMP®

Kartik Gandhi, MS, PMP®, has extensive work experience in the pharmaceutical industry. Currently, they serve as a Senior Quality Assurance Associate and System Manager at Solaris Pharma Corporation since January 2020. Prior to this, they also held the position of Quality Assurance Associate and System Manager at the same company starting in May 2019.

Before joining Solaris Pharma Corporation, Kartik worked as a Senior Global QA Compliance Specialist at Akorn, Inc from November 2018 to May 2019. In this role, they were responsible for reviewing production batch records, change controls, deviations, investigations, and OOS reports to ensure compliance with FDA regulations. Kartik also managed CAPAs resulting from investigations in the manufacturing and QC laboratories.

From March 2017 to November 2018, Kartik worked as a Quality Assurance Specialist at Leading Pharma, LLC. Their responsibilities included issuing and maintaining control documents, organizing quality-related documentation, and reviewing batch laboratory datasheets for the release of finished products, raw materials, and stability.

In 2017, Kartik gained experience as a Quality Control professional at Chromak Research Inc. Kartik conducted analysis of pharmaceutical finished products and raw materials using various test methods and instruments. Kartik also calibrated and maintained laboratory equipment and ensured compliance with cGMP.

Kartik's career started at Lupin in 2012, where they held the position of Quality Assurance Executive from June 2013 to January 2017. In this role, they managed master document control, document cell management, and monitored shop floor activities for compliance with cGMP practices. Prior to this, they worked as a QC Officer, performing routine sample analysis and testing using diverse techniques and instruments.

Earlier in their career, Kartik gained experience as a Quality Assurance Officer at Gufic Biosciences Ltd., where they were involved in auditing new facilities and troubleshooting formulation manufacturing processes. Kartik also worked as a Production Officer at Span Diagnostics Ltd.

Overall, Kartik Gandhi's work experience demonstrates their expertise and proficiency in quality assurance, compliance, document control, and laboratory testing within the pharmaceutical industry.

Kartik Gandhi MS, PMP® has a strong educational background in the field of science and biotechnology. Kartik obtained a Master of Science (M.Sc.) degree in Biotechnology from Bangalore University, where they studied from 2007 to 2009. Prior to that, they completed their Bachelor of Science (B.Sc.) in Medical Technology from Veer Narmad South Gujarat University, Surat, graduating in 2007.

In addition to their academic achievements, Kartik has also pursued various certifications to enhance their professional skills. Kartik obtained a Project Management Professional (PMP) certification from the Project Management Institute in October 2021. In May 2020, they completed the Lean Six Sigma Black Belt (ICBB) certification offered by Sprintzeal. Kartik also holds a Lean Six Sigma Green Belt Certification from Sprintzeal, which they obtained in March 2020. These certifications further demonstrate their commitment to continuous learning and professional development in the field of project management and process improvement.