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

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.

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.