Noven Pharmaceuticals, Inc - Miami, FL
Miami, FL, USA
· The primary purpose of this position is to lead Quality Engineering (QE) activities for product and process support including Validation of Manufacturing Processes, Cleaning Processes, and Test Methods, Qualification of Equipment, Utilities, and Facilities, Risk Management, and Annual Product Reviews.
· Develop and maintain quality engineering methodologies, systems, and practices which meet quality and regulatory requirements. Assure awareness, visibility, and communication to support departmental, functional, site, and corporate quality goals and priorities. Master Statistical Analysis, Product evaluations, Risk Analysis, investigations, qualification/validations as minimum to support Commercial Operations and R&D areas.
· This individual works with minimum supervision using his/her experience, expertise, and sound knowledge to assure the quality of our systems, and products comply with NOVEN policies, procedures, and regulatory...