CAREER SUMMARY Pharmaceutical industry professional with over 20 years of accumulated experiences in GMP production activities involving Active Pharmaceutical Ingredients (API), Execution of Validation protocols, and training of newly hired technicians. Responsible for the sterile/ aseptic manufacturing of nebulizer pharmaceutical products in a FDA regulated aseptic environment utilizing Blow Fill Seal Technology in accordance with Standard Operating Procedures. Actives include the following: dispensing of active pharmaceutical ingredients, bulk formulations (manual and automated) of batch sizes ranging from 1000L to 4000L, performing lot change activities for machine (Clean in place / Sterilize in Place and machine set-up) for commercial activities and operating manufacturing equipment as defined by Manufacturing Production Records. Responsible for maintaining the quality of the product by performing the following: in-Process Quality inspections for fill volume accuracy, vial weight specifications and cosmetic defects. Utilizing data of In-Process Inspections to identify potential negative trends to initiate troubleshooting activities and assist with implementing corrective actions. Performing regular machine inspections to ensure manufacturing equipment and utilities are operating within normal parameters. Responsible for maintaining and monitoring of class 100/10,000 aseptic manufacturing suites through scheduled sanitizations and performing viable / non-viable environmental monitoring of air and surfaces within the clean rooms.

Highlights:

• API
• Application Program Interface
• Clean Room
• Compliance
• Corrective Actions
• Good Manufacturing Practices
• Manufacturing
• Monitoring
• Pharmaceutical
• Pharmaceutical Industry