Location: Dublin, Ireland
Job reference: R-232791
Date posted: 08/01/2025
Position Summary
QC Specialist-Stability and Retain Managementis responsible formaintaining the Stability and RetainProgrammes for allproducts at ADMF and ensures that all activities are fully incompliance with cGMP standards, regulatory commitments and Alexion Standards and Protocols. The QCSpecialist-Stability and Retainsis responsible for performing key quality tasks.
Principal Responsibilities
• Management of stability and retain inventory (DS, DP and Device) for all commercial and relevant clinicalproducts stored at ADMF.
• Ensuring that stability pulls are conducted on time, in adherence with ADMF level-loading principles and that samples are distributed to ADMF labswithin agreed timelines.
• Scheduling of stability pulls and reporting of metrics for pull adherence viaStability Review Board.
• Ensuring that annual retain inspections are conducted on time.
• Authoring Stability Study Documents.
• Enrolling lots into stability and retain studies in LIMS, according to protocols and in partnership with the Stability and QC Sample Management Teams.
• Change management activities in accordance with Alexion procedures.
• Act as stability and retain management SME for Health Authority inspections.
• Identify and implement continuous improvement programs as appropriate.
• Mentoring and training ofcolleagues, as required.
•Shipment of stability and retain samples, as applicable, for external testing.
• Processing additional sample requests.
•Leading and owning Laboratory Investigations and Deviations relating to management of stability and retainprogrammes and sample management.
• Support QC Sample Management activities according to business needs (e.g. aliquoting support, sample distribution, shipments).
Qualifications
• Excellent communication, interpersonal and organizational skills.
• Ability to work well both independently and in a team environment with minimal supervision.
• Ability to prioritize work,multitaskand escalate as appropriate.
• Conducts work in compliance with cGMPs, ICH guidelines and safety and regulatory requirements.
• Takes a structured, analytical approach to problem solving.
Education
• Degree in chemistry or biological science with a minimum of 5 years experience in the Pharmaceutical/BiotechnologyIndustry.
• Computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheetapplications isrequired.
• Experience in the use of Electronic Document Management and Quality Management Systems is an advantage.

Please refer the Job description for details