Sachin Patel

About Sachin Patel

Experienced Coordinator with a demonstrated history of working in the pharmaceuticals industry. Skilled in U.S. Food and Drug Administration (FDA), Verification and Validation (V&V), Corrective and Preventive Action (CAPA), Good Laboratory Practice (GLP), and Change Control. Strong professional graduated from Sayaji & M. S. University.

Experience

1. Qa Manager

   Amneal Pharmaceuticals

   Mar 2014 — Present · US

   Reporting to Director - Quality Management • Oversaw entire QA operations and Management systems with ten direct reports for multiple facilities located at Paterson, and East Hanover covered in NJ. • Maintains Quality Assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and approaching job results.• Maintains Product Quality by enforcing Quality assurance policies and procedures and regulatory requirements; collaborating with other members of management to develop systems and training methods. • Ensures the completion of internal audits of the quality system and other departments across all sites in NJ. • Handling of Quality related market complaints. • Handling of unplanned deviations (Notice of investigations) related to manufacturing, engineering, regulatory and quality control. • Performs root cause analysis and other problem solving activities to identify effective corrective actions and process improvements. • Review and approval of Change controls via QUMAS process.• Provide Quality oversight of CMO’s for amneal distributed products at the validation, launch, and commercial stages of the product life cycle.• Ensure review of batch documentation and disposition of CMO’s manufactured product shipments for distribution in the US market.• Ensure that change controls, deviations & investigations, CAPA’s, Annual product reviews, complaints, stability program and retain sample management systems are in compliance for CMO manufactured products. • Assists Director-Global Quality Management Systems in the preparation and submission of Field Alert Reports to FDA local district office. • Assists Director-Global Quality Management Systems in the preparation of FDA-483 Observations. • Responsible for performance management/appraisals and hiring of the employees within QA department for all NJ-facilities.