Vatsal Gandhi

-Ensure and maintain quality on the Bottling, Blistering, and Cartoning lines of various Nutraceutical, OTC, Prescription (Rx), and Class IV products according to FDA cGMP CFR 210 & 211 and company SOP -Responsible to make sure all testing equipment like weighing scales, counters, heaters, torque tester, vacuum tanks are properly calibrated and calibration sticker is checked before using for inspection as per cGMP requirements. Log books for each equipment is maintained as per GDP -Assist quality engineers/technicians in validation for equipment in Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) -Set up and troubleshoot the serialization systems- Systech and ACG along with IT technicians for Rx products. -Responsible to perform line clearance, along with approving and documenting line cleaning, to confirm that there is no chance of cross contamination or product mixup during changeovers -Verify and document primary and secondary components according to Certificate of Compliance (COC), Certificate of Analysis (COA) provided by the customer and company specification in the batch record -Conduct “First Run Protocols” & “Stability Runs” to determine process parameters for packaging new products. -Set the process parameters of the production line, conduct in-process inspections and document the results -Carry out reconciliation of all the components and document it at the end of each batch -Design and verify labels for different packaging materials, in-process and finished products -Control and reconcile printed components like labels, cartons, insert and printmats -Train line personnel in packaging rooms on proper cGMP regulations and packaging instructions. -Maintain the Batch Record in respect to FDA CFR 211.188, Good Documentation Practices & company SOP -Coordinate with QA supervisor and Production Heads to investigate, solve and document non-conformance/CAPA -Second peer review of batch records, SOP’s

• Organize and manage the university computer lab • Greet and assist in technical difficulties faced by students using the lab • Assist the university Laptop Shop

• Record and update personal information of university alumni using Banner System • Accounting and filing of alumni donations to university

• Conducted several QC testing on manufactured capsule shells like disintegration test, dissolution test, weight variation, content uniformity, assay, and moisture permeation test in accordance with GLP/GMP • Recorded and compiled the QC test data • Reviewed packaging and labeling before releasing the batch • Evaluate test documents like SOP, DMF, Test Protocol and CMC Amendments required for regulatory submissions • Collaborated closely with other departments and external CRO to streamline the QA/QC process