The Drug Product (DP) Manufacturing Associate

Description

Main duties will include: The Drug Product (DP) Manufacturing Associate will be a key member in supporting the execution of operational readiness at the Alexion Athlone Manufacturing Facility. The Manufacturing Associate will be an SME in a number of unit operations throughout the Fill Finish manufacturing process and will be responsible for execution of batch operations as per standard operating procedures under limited supervision. Responsibilities: • Operate manufacturing equipment and instruments and complete assigned tasks in a timely manner • Execute the production schedule / plan on a day-to-day basis to meet production forecast and the required output • Perform daily / weekly /monthly internal calibrations and verification checks ensure all documentation is complete in a timely manner • Provide Technical support for troubleshooting equipment and process activities • Complete Master Batch Records (MBRs), logbook entries and any required GMP documentation to cGDP • Prepare, review and approve MBRs, SOPs and logbooks • Perform logbook reviews to ensure all documentation is in line with audit readiness • Record and update production metrics • Ensure all training is performed in full and completed in a timely manner • Ensue all tasks performed are compliant with cGMP and EHS guidelines • Work as a team to support, develop and encourage collaboration with all departments to work as one team on site • Ensure all production deviations are raised with Production Supervisor / QA immediately • Support Root Cause Analyse for all quality deviations within the production areas, complete assigned CAPA actions within the designated timeframe • Support the creation of EHS task risk assessments within the production areas • Report any machine issues (Downtime or Rejects) to the Team Supervisor and to the maintenance department • Assume responsibility for the day to day housekeeping duties within the assembly area • Routinely draft/ create and revise standard operating procedures, manufacturing batch records and other documents as required • Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved • Embrace Alexion Core Competencies • Aseptic Filling with RABS in grade B background • Compounding / Formulation of products • Sterile Filling of vials / syringes using Isolator • Visual Inspection of finished product. • Cleaning and Sanitation of equipment