Operation Support Specialist (Secondment)
Alexion Pharmaceuticals · Athlone, Leinster, IE
This is what you will do: The Operations Support Specialist is responsible for driving support functions related to the drug substance manufacturing operatio...
Job description
This is what you will do: The Operations Support Specialist is responsible for driving support functions related to the drug substance manufacturing operations at the Alexion Athlone Facility and for ensuring that all operational support activities are completed in a safe manner and in compliance with cGMPs and regulatory filings. The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives and policies in a professional and responsible manner. You will be responsible for: - Manage and coordinate the creation and revision of operations documentation in line with schedule requirements - Act as a Subject Matter Expert in operations related Vault processes and procedural requirements, providing leadership and expertise where required - Act as Subject Matter Expert in Trackwise/ EQV processes, taking the lead in all Operations related investigations and systems including technical writing, deviations, corrective actions and change control, providing leadership and expertise where required - Create and Review batch records and other manufacturing process records - Support the approval of raw materials and consumables - Support continuous improvem...