Descripción del Empleo
This position is responsible for effective and efficient product development progression and to build and train productio team. Work with the team to setup manufacture and complete related validation to ensure the manufacture meeting GMP requirement.
• Follow SOP for new batch product optimization, testing and ensure released product meeting product QC specification.
• Understand production process, evaluate the existing production technology and make necessary changes for process improvement, optimization and cost reduction.
• Establish quality control for production process by stabilizing technical level.
• Evaluate and introduce new production technology for product quality improvement. Provide input on production technical related issue and improvement to R&D.
• Research and introduce new production equipment for product quality improvement and cost reduction.
• Source backup materials for major product components
• Responsible for verification of complaint, approval of effectiveness/modification of new product technology transfer documents, review of all reports and proposals on technology-related materials, equipment, and production process validation, and reports on CAPA and investigations on non-qualified products and abnormality.
• Communicate with the technical team to ensure any issue and problem in production will be solved within target timeline.
Experience and requirements:
• Bachelor´s degree in biology, chemical engineering, pharmacy or related field is required.
• 3 or more years of experience.
• Experience in medical devices industry (preferred).
• Bilingual (Spanish - English).