Jignesh Jayantibhai Donga

About Jignesh Jayantibhai Donga

14.7+ Yrs. of experienced and skilled scientist in the pharmaceutical industry, I have a…

Experience

1. Senior Manager

   Ipca Laboratories Limited

   Jun 2025 — Present

   Leads the entire formulation plant for trial process, including New product evaluation, process improvement, process excellence, AVD products and process feasibility assessment. This encompasses:==> Planning and Execution: Design and Execute R&D trials to evaluate product performance and assess process feasibility.==> Batch Management: Oversee The Planning, Execution, and Monitoring of Trial, Scale-Up, Engineering, Exhibit, And Validation Batches at the manufacturing location.==> Pre-Trial Preparation: Ensure All Resources are available for the Trial, including Materials, Tooling, Equipment, and Personnel. Conduct Gap Analysis to Identify and Address Potential Issues.==> Batch Size Optimization: Calculate and select optimal batch sizes considering equipment capacity and manufacturing steps for both exhibit batches and intended commercial production.==> Innovation: Conduct GAP analysis and utilize product history data to identify opportunities for new product development and process improvement.==> Change Control: Manage deviations from the plan, investigate causes, implement corrective actions (CAPA), and ensure timely closure of deviation reports.==> Product Improvement: Troubleshoot technical issues in existing products, conduct trials to test solutions, and propose changes for improvement.==> Documentation: Prepare key documents like Technology Transfer Protocols, Batch Manufacturing Records, and Sampling plans.==> Process Capability Analysis: Analyze process data to assess product quality and identify areas for improvement. Communicate potential risks to relevant stakeholders.==> Project Management: Develop project strategy, timeline, and micro-schedule. Coordinate effectively with cross-functional teams (Project Management, Production Planning, QA, QC, Regulatory Affairs, R&D, and Production) to ensure project completion.==> Regulatory Compliance: Respond to queries from regulatory bodies regarding exhibit batches and site transfer products.

Education

• Shree Swaminarayan Gurukul Vidyalay, Surat

  12 th science, Science Stream

  2003 — 2005

• Vidyabharti trust college of pharmacy

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  2005 — 2009

• Sumandeep Vidyapeeth University, Piparya Vadodara.

  Master of Pharmacy in Pharmaceutics Department , Pharmaceutics

  2009 — 2011