Germany
• Successfully transferred the Granulation process to a 3rd party manufacturer in India, giving the site greater flexibility within our granulation suites for new formulation and scale up capacity for new and existing products. • Eliminated a recurring process issue in a high volume product, which allowed production to continue uninterrupted, allowed equipment to run at maximum speed and alleviated the need for product to go on hold and interruption to supply as a result. • Scaled up a new global product and optimised the process before validation and launch. After a year of production process capabilities are acceptable, and there have been no batch failures or processing issues. • Identified poor run ability of a tablet press on a specific product. Identified corrective actions, then co-ordinated and implemented those action. The result was that the routing time on the press were reduced on a batch by batch basis from 54hrs to 26hrs.
Commissioning Syringe Filling line Isolators. On site FAT and Client site SAT and IQ / OQ
Commissioning Syringe Filling line Isolators. On site FAT and Client site SAT and IQ / OQ
Project works, with: @ MSD Co. Carlow & Tipperary. TOP (TurnOverPack), IQ, OQ, and Validation Lifecycle Management For Vial and Syringe filling Lines Equipment Qualifications. Direct team engagement with strong communication skills and Conflict management skillset. Fire watch safety officer, permit co-ordinator.
CQV Lead coordinating the qualification activities for Process Support Equipment / Warehouse and QC Labs.
CQV Lead at Lonza Bio systems, ensuring correct implementation as per procedures. Qualification of new equipment related to vial filling as well as laboratory equipment.
Validation to upgrade related packaging lines, and integration of new machines where applicable.