Responsible for achieving the validation master plan and calibration programme to ensure the effectiveness of the QMS and proper functioning of the internal calibration laboratory. Work alongside product managers, project managers, and developers to maintain quality throughout the product lifecycle through active management of QMS processes based on current legislation and regulations focused on risk analysis.Draft and review documentation related to QMS processes as applicable.Participate in maintaining risk analysis of QMS processes.Track and maintain key performance indicators (KPIs).Inspect the production plant frequently to verify on-site process control and compliance with procedures, and train staff on modifications as necessary.Organize and lead quality meetings to ensure the effectiveness of the Quality Management System.Identify and propose opportunities for improvement of the QMS.Related to manufacturing transfer process:
Transfer from design to production regarding control plans and control methods.Train factory personnel.Support design and construction of test rigs for design and/or manufacturing.Manage change controls related to in-house and subcontracted manufacturing processes.Related to validation process:
Write protocols, participate in execution and reporting of validations.Monitor validation plan progress and report to management.Prepare validation maintenance reports and monitor equipment, facilities, and services.Evaluate trends.Validate clean rooms, ethylene oxide and wet steam sterilization systems, and computerized systems.Qualifications include a Bachelor's degree in Industrial Engineering (preferably), with preferred courses or specializations in ISO standards, GAMP5, GMP, microbiology, metrology, and proficiency in English and Microsoft Office. Experience working in ERP environments is also preferred.Skills required include attention to detail, analytical thinking, proactivity, collaboration, leadership, and communication skills.
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