Senior Manager Quality Assurance Validation- Cell and Gene Therapy Catalent Pharma Solutions BioPark
| Pharmaceutics International, Inc
Strategic thinker ●.Excellent communicator ● Creative negotiator ● Logical problem solver Implementation ● Integration ● Global Materials Management ● Quality Assurance Passion for technology with ability to develop and implement new business opportunities Leadership skills with keen vision, economic sensitivity and analytical skills. An innovative Quality Engineer with a strong career of domestic and international work experience in progressively more responsible positions with a variety of industries with large capital equipment, combining vision, technical prowess and business-management expertise. Background and work experience range from process/project chemical engineering in R&D and analytical labs, and manufacturing facilities (Biotechnology, Pharmaceutical, Medical Devices, Department of Defense and Aerospace industry, Automotive, Printing, and Polymers industry) with areas of focus on: •New Product Development and Transfer Technology •Product sustaining and yield enhancement •Foundry business and process technical support •Project Management •Quality, reliability and failure analysis (RCA- Root Cause Analysis) •Product and Process Validation •Equipment Installation, Operation and Performance Qualification. Enforce work standards, write standard operation procedures, work instructions, train personnel, review and resolve work discrepancies to ensure compliance with contract requirements, domestic and international regulatory legislation (FDA/EU, cGMP, OSHA, ISO 9000). Execute operational excellence initiatives and specific computer applications as: •DMAIC (Define, Measure, Analyze, Implement and Control) •6 Sigma (5S +1) (Champion Certificate holder) •Statistical data analysis (DOE) (Design of Experiments) •Microsoft Office (Word, Excel, Power Point, Project, Access) •Visio, JMP, DOORS, ORACLE, AGILE, SAP, ApplicationXtender, EMARS, VEEVA.
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