Christopher Smith Email & Phone Number

Grand Island, Ny

Grand Island, New York

Responsible for Quality System continuous improvement project and system enhancements.

2437 William St. Cheektowaga, Ny

Bar & Restaurant

Grand Island, New York

In charge of cGMP Compliance for multiple Quality Assurance Systems, including Complaint & Deviation Management, Document Control, and Annual Product Review.• Manage the Customer Complaint and Deviation Systems through nine investigators, ensuring the timely completion of quality stand alone investigations. • Authored and executed a complete content overhaul of the Annual Product Quality Review, ensuring compliance to FDA, Q10, and EMEA standards.• Author, transmit and… Show more In charge of cGMP Compliance for multiple Quality Assurance Systems, including Complaint & Deviation Management, Document Control, and Annual Product Review.• Manage the Customer Complaint and Deviation Systems through nine investigators, ensuring the timely completion of quality stand alone investigations. • Authored and executed a complete content overhaul of the Annual Product Quality Review, ensuring compliance to FDA, Q10, and EMEA standards.• Author, transmit and track required FDA correspondence (i.e., audit observations, field alerts, recalls).• Manage all cGMP Documentation, including document retention and archiving, ensuring FDA Compliance.• Authored Corporate Gap Assessment and Risk Assessment Policy as part of Q9 Compliance.• Reengineered the Batch Record to ensure FDA and ANDA compliance, including Batch Record presentation and document tracking procedures in line with industry standards. Show less

Grand Island, New York

Managed Aseptic filling department on 2nd shift, including Vial/Stopper Preparation, Sterilization, Filling/Capping, Inspection, Packaging, and Warehouse activities.Authored and executed a waste reduction and departmental continuous improvement plan in line with lean manufacturing principles.Responsible for all aspects of the 2nd shift operation, including budgetary, FDA compliance, and staffing concerns.