Nirvi Patel Email & Phone Number

Kansas City, Missouri Area

• Perform thorough review of batch records and supporting documents to support the final disposition of the products to meet market demands• Notifies QA Management of any discrepancy or deviations, and provide support to the investigation team by performing and Tracking Deviations, Investigations, Product Complaints and CAPAs.• Writes, reviews deviations, investigations, implements CAPA and its effectiveness and provides support to the investigation team• Performs product inquires and product complaints.• Performs review of raw materials and finished product certificate of analysis• Assists in release of raw materials and finished product• Creates new and revised Nostrum Laboratories, Inc. procedures and forms as necessary to ensure that current practices are accurately documented and adequately followed• Review the requirements of batch records, SOPs, test methods, validation protocols, validation reports, calibration, and change control records to administer quality and compliance into products and processes• Perform Internal Audits as required.• Perform AQL and In-process checks during the production processes to support the product quality.• Perform Quality clearance for rooms, equipment, ancillary parts and verify the staged materials for manufacturing use.• Function as “hub” coordinating key activities and deadlines are met as required to ensure complete compliance prior to batch release.• Assist actively during FDA inspections. • Training and developing junior associates as and when required.

Kansas City, Missouri Area

ASQ CQPA Certified (2012)• Reviewing all production batch record and support the final disposition of the products.• Notifies QA Management of any discrepancy or deviations, and provide support to the investigation team by performing and Tracking Deviations, Investigations, Product Complaints and CAPAs.• To perform internal audits as required. • Review Laboratory data including ARFs and COAs.• Review the requirements of batch records, SOPs, test methods, validation protocols, validation reports, calibration, and change control records to administer quality and compliance into products and processes.• Generate new and revise the existing Nostrum Laboratories, Inc. procedures and forms as necessary to ensure that current practices are accurately documented and adequately followed.• Monitor and enforce overall cGMP compliance requirements as specified in Nostrum Laboratories, Inc. SOPs, test methods, and batch records• Perform Quality clearance for rooms, equipment, ancillary parts and verify the staged materials for manufacturing use.• Perform AQL and In-process checks during the production processes to support the product quality• Perform daily floor Audits.• Providing training to new associates.• Formatting and revising of cGMP documentation including SOPs, Forms, Specifications, Master Batch Records, Test Methods and Document Change Request records. • Issuance and maintaining of logbooks used in all production production processes.

Farmigdale, Ny

• Perform Sampling of Raw materials, API.• Reviewing of COA/COC, SOP, GMP documentation.• Perform quality checks like hardness, thickness, weight variation, friability on the bulk product.• Handling of retention samples and inventory log.