This Is What You Will Do
The Qualified Person works with the site QA function at the Athlone manufacturing facility 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 role is a key member of the local quality team and ensures effective interaction with other departments locations. In particular, this will involve partnering with major stakeholders such as Manufacturing, Engineering, Technical Services and QC to optimize patient supply.
As qualified person, this function is required to ensure that practices at Alexion Pharma International Trading are in compliance with Directive 2003/94/EC and the Rules and Guidance for Pharmaceutical manufacturers and Distributors 2014. They should provide oversight of the site quality systems at Alexion’s facilities. The Qualified Person is responsible for oversight of manufacture and testing of the drug substance/product.
The position sits at the Athlone site and contributes to the overall quality strategy on site.
You Will Be Responsible For
* Perform the routine duties of the Qualified Person (QP) and certify batches for release within the European Community in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 of the EU Guide to Good Manufacturing Practice and Company Procedures
* To provide technical expertise for all QA and compliance topics / issues relating to Alexion manufacturing, ongoing compliance and product supply.
* Acts as quality point of contact, providing guidance and feedback relating to quality assurance operations, approaches to deviation investigations and improvements to ensure robust and efficient quality performance.
* Provide sound QA support to manufacturing, engineering, utilities and material movement (including cold chain) for both clinical and commercial products.
* Provide leadership for deviation investigations, including root cause analysis, and corrective and preventive action (CAPAs) proposals and initiatives.
* Drive compliance to quality metrics while maintaining high quality standards and implements course corrections when metrics or quality deliverables are off track.
* Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports.
* Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities during health authority inspections including leading audits with inspectors, responses to inspection observations and monitoring progress of follow up actions.
* Engages with the local QLT to holistically ensure a quality culture in line with Alexion values and in support of an inspection ready site.
* Provide sound QA and Compliance support and training to quality resources to ensure quality decisions, oversight and activities are delivered to a consistently compliant standard.
* Ensure practices and products released from the site are in compliance with cGMP as stated in Directive 2003/94/EC and in the Rules and Guidance for Pharmaceutical manufacturers and Distributors 2014.
* For selected products, ensure that manufacturing and testing activities undertaken at other facilities, both Alexion and contractors are conducted in compliance with GMP or equivalent.
You Will Need To Have
* Third level qualification eg., B.Sc in science/pharmacy with a minimum of 10 years experience in cGMP Quality environment; or equivalent combination of education and experience.
* Minimum of 5 years registered as a Qualified Person on a manufacturing
authorisation issued by a European Competent Authority for medicinal
products
Direct experience of GMP within a pharma/biopharma company and will include exposure to HPRA, FDA, or other authorities of similar standing.
* Planning and organising skills are required to plan, execute and track
commitments of Quality Assurance and to adjust to changing priorities.
* The duties of this role are generally conducted in an office environment and in a pharmaceutical manufacturing environment.
* As is typical of a pharmaceutical manufacturing based role, employees must be able, with or without an accommodation to: frequently lift/carry 15/30 pounds unassisted/assisted; stand for prolonged periods of time; walk and move for prolonged periods of time; climb stairs or ladders; gown/de-gown PPE and uniforms; use a computer with a keyboard and mouse; collaborate with others; maintain general availability during standard business hours.
We Would Prefer For You To Have
* Master’s degree fulfilling the educational requirements required by European Directive 2001/83/EC and 2001/82/EC, unless the bachelor’s degree already meets these.
* Experience in one or more of the following:
* Strong technical process knowledge across drug substance and drug product manufacture.
* Extensive experience in quality oversight of validation of new equipment, new products and process changes.
* Extensive experience in Quality Management Systems and Risk Management.
* Excellent interpersonal skills are required, as is the ability to communicate
* Actively contributes to continuous improvement activities.
Date Posted
01-Aug-2025
Closing Date
29-Aug-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. #J-18808-Ljbffr