Manufacturing Associate

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

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.

YOU WILL BE RESPONSIBLE FOR:

• Operate manufacturing equipment and instruments and complete assigned tasks in a timely manner
• Support the production schedule to meet forecast and the required output.
• Perform daily / weekly /monthly checks to ensure all documentation is complete as per ALCOA+ data integrity principles.
• Complete Master Batch Records (MBRs), logbook entries and any required GMP documentation to cGDP.
• Perform logbook reviews to ensure all documentation is in line with audit readiness.
• Ensure all training is performed in full and completed in a timely manner.
• Ensue all tasks performed are compliant with cGMP and EHS guidelines.
• Working 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 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.
• Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
• Embrace and adhere to Alexion, Astrazeneca Rare Disease Values.
• Aseptic Filling and support function process training.
• Visual Inspection of finished product.
• Routine Cleaning and Sanitation of equipment and classified areas