Nayna Patel

• Managed the stability program as per cGMP and under compliance that include the following taskso Placing the product into appropriate stability chamber and withdrawing stability sample as per stability protocolo Scheduling testing, reviewing data, entering and trending data into ScienTek software.o Preparing APR report for all the marketed product to support current expiration date of the producto Submitting stability data for annual filing for ANDA productso Supported Finish product release, customer complaint, and deviation during manufacturing with stability data, and extending expiration dateo In case of confirmed stability failure warranted recall of the product from the marketo Maintained all stability chambers in compliance• Created and edited SOPs, Chemical Testing Monographs for finished products and raw materials, specification and analysis reports for finished product, stability and raw material.• Generate stability protocols for G&W drug products • Effectively managed all QC activities that include scheduling work to the chemists, reviewing data for FDA and cGMP compliance, releasing raw materials, in-process, finished products, stability samples, process validation and complaint samples. • Provided training on lab procedures• Conducted performance evaluation on yearly basis • Prepared OOS and OOT reports • Interacted with outside labs and vendors for storage and/or testing of stability samples and resolve issues related to OOS.• Created Residual Solvent Statements for G & W drug products as per USP/FDA requirements. • Reviewed IQ/OQ/PQ protocols and SOPs generated by the Metrologist • Developed, documented and implemented programs for in-house standard verification and Vendor qualification of raw materials.• Actively interacted with FDA outside Auditors during FDA inspections and audit• Interacted with other department such as QA, ARMD, TS, and RA to provide various informationSpecialties: • Maintained Empower program used in the lab to collect chromatographic datao Created custom project (about 200) for finished products, raw materials and equipment calibration o Each project is product specific and is created to generate reports with the final results (automatic calculations) and audit trail information. O Created new versions and Archive Projectso Train chemists in the operation of the Empower software and troubleshooting problems related to Empower operation