Carlow, County Carlow, Ireland
Experienced Manufacturing with a demonstrated history of working in the pharmaceuticals industry. SME & qualification of Autoclave and Parts Washer in Fill Finish manufacturing. Strong professional with a BSc (Ord) Degree in Manufacture of Medicinal Products focused in Pharmaceutical Sciences from Dublin Institute of Technology.
MSAT Engineering Team member Executing and support of Parts Washer FAT & SAT Executing and support of Autoclave FAT & SAT Cycle Development & PQ execution of Parts Washer and Autoclave equipment SME Parts Washer, Autoclave and FIT. Review of SAR and C&Q documentation. Developing of SOPs for Fill Finish prep areas.
Factory Acceptance Testing Site Acceptance Testing Risk Assessment FMEA HAZOP URS & Functional Specifications execution Updating and reviewing of SOPs for use and audit readiness. Filter Integrity Testing of Pre-& Post used filters for supporting of production Sterility assurance through Autoclave operations Formulation of Product Vessels. (SIP, CIP, WFI) Preparation of production by means of downloading and confirming of Scada recipes and confirming through Manufacturing Execution Systems. Line Clearance and Preparation. Following Company Standards and Standard Operating Procedures. Adhere to current Good Manufacturing and Documentation Practice. Operation of production units, Washer, Tunnel and Tray-off. Inventory movement and return from Kanban to be used in Fill Finish operations. Grade B training for operation in a Class B Cleanroom environment. 5S and general housekeeping.
Packaging Inspection & Validation Component Release Validation Inspections