Senior Specialist, Quality Assurance- Drug Product(12 months fixed term)

This is what you will do:
Responsible for delivery of quality assurance activities at Alexion’s Irish locations to ensure commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements. This responsibility requires the delivery of QA and compliance support for the Irish site(s).
The Quality Assurance Specialist executes the site QA activities at Alexion in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Manufacturing, QC, QPs, Site Services, Engineering and Planning to optimize patient supply.

You will be responsible for:
•    Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to Alexion manufacturing and product supply.
•    Acts as quality point person, providing guidance and feedback on quality assurance issues.
•    Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk.
•    Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups.
•    Provide advice on GxP within the site, with reference to guidelines and regulations.
•    Support technology transfers and new product introductions.
•    Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
•    Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.
•    Provide quality oversight of Validation activities for the site.
•    Support QP batch release activities to maintain release schedule.
•    Actively support audit readiness activities and regulatory agency and internal audits.
•    Actively contributes to continuous improvement activities.
•    Lead coordination of referrals of regulatory documentation (e.g. dossiers, site impact assessment, annual reports, or QP declarations) and market-specific documentation for site accreditations and product reviews.
•    Actively engage in process improvements and risk assessments, such as benchmarking internal and external quality assurance practices to identify innovative efficient and effective practices.
•    Conduct data analysis and development of reports and insights on quality metrics and key performance indicators, using digital tools and processes.
•    Support overall planning around quality training and guidance for internal / external stakeholders for area.
•    Guide early-career team members around quality processes, related digital tools, nd compliance requirements.
•    Acts as delegate for QA management 

Date Posted

17-Jul-2025

Closing Date

23-Jul-2025

Our 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.