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 improvement initiatives by identifying areas needing improvement, recommending strategies for improvement and implementing the strategies once approved
• Support Regulatory licensure activities including agency inspections and submission preparations. Provide expertise and leadership in formulating inspection responses
• Lead and ensure the timely close out of any process related changes
• Manage Audit preparation ensuring the manufacturing suite and related areas are presented in a GMP compliant state
• Troubleshoot and resolve operational problems during processing where required
• Support multiple projects including product transfers, new product introductions and new material introductions

You will need to have:

• Experience with Vault, Trackwise or related documentation system
• Experience with SAP or related ERP system
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections
• Good interpersonal, communication and problem solving skills
• Should be knowledgeable of regulatory and GMP requirements

We would prefer for you to have:

• BA/BSc. in a scientific discipline or equivalent experience preferred.
• 4 years’ experience in operations in a GMP environment with demonstrated technical investigational ability

Date Posted

13-maj-2026

Closing Date

27-maj-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.