Job Description

Operations Support Specialist (12-month Secondment/Fixed Term Contract)

Location: Monksland, Athlone

Opening date: 02/04/2026

Closing date: midnight 15/04/2026

37.5 hours per week, day role, Monday to Friday

As an Operations Support Specialist, you will play a key role in supporting drug product manufacturing activities at the Alexion Athlone Manufacturing Facility. You will ensure all operational support processes are delivered safely, efficiently, and in full compliance with cGMP and regulatory requirements. In this high‑impact role, you will represent the Alexion AstraZeneca Rare Disease Unit with integrity, demonstrating our commitment to quality, innovation, and patient-focused values.

Accountabilities:

• Lead and coordinate the creation, review, and revision of operations documentation in alignment with production schedules.
• Serve as a Subject Matter Expert (SME) for operations‑related EDMS processes, offering mentorship and leadership as the need arises.
• Act as an SME within the Quality Management System (QMS), leading Operations-related investigations and documentation including deviations, CAPAs, change controls, and technical writing.
• Ensure timely closure of process-related changes, deviations, and investigations.
• Develop and review batch records and associated manufacturing documentation.
• Drive and support continuous improvement activities by finding opportunities, recommending solutions, and implementing approved improvements.
• Perform data collection, compilation, and statistical analysis to support operational decision-making.
• Monitor process trends and implement improvement strategies where appropriate.
• Lead and support multiple projects such as product transfers, new product and equipment introductions, and introduction of new materials.
• Support regulatory licensure activities, including inspections and submission preparation; provide expertise in developing inspection responses.
• Lead audit readiness activities, ensuring manufacturing and associated areas maintain GMP compliance.
• Troubleshoot and resolve operational issues during production when required.

Essential Skills/Experience:

• Good technical capabilities, collaboration abilities and initiative.
• Good interpersonal, communication and problem-solving skills.
• Ability to work independently and as part of a team.
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
• Should be knowledgeable of regulatory and GMP requirements.

Desirable Skills/Experience:

• BA/BSc or equivalent, either completed or in progress in a scientific or science-related field.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll find an environment where innovation thrives! Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio, you'll enjoy the entrepreneurial spirit of a leading biotech while being supported by exceptional leaders. Embrace tailored development programs that align your growth with our mission. Here, your career is not just a path but a journey to making a difference where it truly counts.

Ready to join us on this exciting journey? Apply now!

Date Posted

02-Apr-2026

Closing Date

15-Apr-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.