Senior QA Specialist, Finished Product (12 month FTC) at AstraZeneca

Dublin, Leinster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

14 Mar, 26

Salary

0.0

Posted On

14 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Pharmaceutical Industry, Biotech Industry, Packaging Experience, Quality Risk Assessment, Root Cause Analysis, Change Control, Documentation Review, Batch Release, Inspection Readiness, Continuous Improvement, Interpersonal Skills, Communication Skills, Regulatory Compliance, Team Collaboration, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

Senior QA Specialist, Finished Product (12 month FTC) Location: Dublin College Park Day Role - 37.5 hours per week Introduction to role: Are you ready to make a difference in the world of biopharmaceuticals? As a Senior QA Specialist at our College Park facility, you'll play a pivotal role in ensuring the quality and compliance of packaging activities for both commercial and clinical products. With management support, you'll oversee the testing, packaging, labelling, and storage of Alexion products, ensuring they meet QMS and regulatory standards. Collaborate with various departments and stakeholders to optimise patient supply and drive quality culture. Are you up for the challenge? Accountabilities: Review and approve documentation for packaging technology and equipment validation as required Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/controlled Provide Quality input, oversight, and guidance to Alexion deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per Alexion SOPs and QMS Provide Quality input, oversight, and guidance to Alexion change controls including NPI to ensure they are raised and progressed in a compliant and timely manner according to Alexion SOPs and QMS Review and approval of functional area documentation (SOPs, PIs, Work Instructions, technical reports, and protocols) Perform issuance and review of batch documentation and support the QP team in relation to preparation and review of the relevant documentation for batch release and ensure post-release tasks are complete to allow in-country release Author, Review, and Approval of QAGs Author and review relevant chapters of product quality reviews Leading investigation actions assigned to College Park from complaints process Provide support and expertise for inspection readiness activities during health authority inspections including interaction with inspectors, responses to inspection observations, and monitor progress of follow-up actions Support the drive of Quality Culture and support implementation of continuous improvements at College Park in Compliance Act as designee for QA Manager in their absence Essential Skills/Experience: Bachelor's degree in science, engineering or equivalent Proven QA experience in international pharmaceutical and/or biotech industry with packaging experience a preference Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements Ability to prioiritise daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization Strong verbal and written communication skills with well-structured communication and presentation ability 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 five 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 12-Dec-2025 Closing Date 04-Jan-2026 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.

Responsibilities

The Senior QA Specialist will oversee the quality and compliance of packaging activities for commercial and clinical products, ensuring they meet regulatory standards. This includes reviewing documentation, participating in quality risk assessments, and providing oversight for deviations and investigations.