Miguel Torres

BS Licensed Chemist/ ASQ Certified Quality Auditor, MBA PM with experience in the Pharmaceutical Industry in the QA/QC Area. Experience in the Raw Material, Solid Dosage, Method Transfer and Stability Laboratories Environment. Scientific and Supervisory role and tasks. Supervise and develop Staff completing routine change control activities and resolving frequently complex change control issues following cGMP regulations and standards. Supervise performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment. Coach and develop staff and provide regularly scheduled feedback throughout the year. Experience working with Laboratory and Manufacturing Investigations, Root Cause Analysis, Trend Analysis, CAPA and CAPA Effectiveness. Experience reviewing and approving analytical data reports and test results. Knowledge, Setups and Troubleshooting of several laboratory instruments (HPLC, UV, FTIR among others). Instrument qualification (IOQ/PQ). Test method transfer/validation activities. Experience in LIMS, Trackwise, GQMS, Atlas and MPower acquisition system. Write/update SOP's, Test Methods and Equipment Protocols under CR's and VMS system. New Supplier and/or alternate source qualifications. Laboratory and Internal Audits. Effective skills of analytical thinking, problems solving, interpersonal relationships, planning/organization, meeting development and participation. Effective interactions in a team environment. Good organizational skills, detail oriented and accurate, analytical skills, effective verbal and written communications skills. Knowledge of cGMP, GLP, Quality System and FDA regulations. ·Zero 483 for FDA inspection output for the laboratory department. ·Silver Award for FDA zero audit observation achievement. ·Silver Awards for zero human error investigation ·Meets departmental Quality Goals and Objectives (reduced backlogs, cycle time, investigation events etc)