Jorge Cordero

Validation Manager @博士伦

Experienced manager with a demonstrated history of working in the pharmaceuticals/medical device industry. Skilled in Pharmaceutical and Medical Devices, EU and U.S. Food and Drug Administration (FDA) regulations, Root Cause Analysis, and all validation areas. Strong quality assurance and engineering professional background with a MBA focused in Global Management. Also, speaker on local and international conferences. Manager responsibilities: Supervising over 12 people in addition to over 5 consultants on peak projects. Performing managerial activities such as performance reviews, department budget, and hiring, discipline and layoff personnel, as necessary. Validation SME responsibilities: Serve as SME for all validation areas and risk-based approach at B+L Greenville, SC site, B+L Corporate and MDR for aseptic simulation processes, water systems, sterilization processes and airflow pattern. Redesigned validation department and validation programs, Air visualization, Process Validation, and Aseptic Simulation Program. Risk-Based Approach: Successful implementation of risk-based approach on equipment and cleaning validation by implementing verification test reducing qualification time on simple changes in 75%, process validation by reducing validation and implementation cost (ex.$1.6 million saving on new product introduction), and aseptic simulations on new component introduction by reducing media fill runs in 80%. Areas of support: Reviewing and approving all PM, calibration specifications, Batch Records, Change Request, and SOPs for GMP critical equipment, processes and instruments. Local Change Control core team member and Bausch Health Global Validation Core team member. Speaker: Speaking in conference since 2012 for companies like IVT and KenX across US, Ireland, and Amsterdam with a combine total of 27 presentations related to multiple validation disciplines Warehouse mapping, change control, risk assessment among others.