QC Specialist NPI

Alexion • Full-time • Dublin, Ireland • 1w ago

Thisis whatyouwill do:

The QC Specialistis responsible for technical and quality oversight for Transfer and Validation Activities within the Chemistry and Biochemistry Labs.

Youwill beresponsiblefor:

Driving the validation and transfer of Chemistry and Biochemistrytest methods and test systems in support of in-process and commercial release testing

Author/ review and approval of laboratory validation protocols /reports as required

Critically assess test procedures, analytical validation/transfer reports for accuracy and propose improvements/enhancements.

Perform review of regulatory submissions

Support the introduction of automation and rapid techniques within QC and the implementation of analytical changes

PerformingtechnicalreviewandapprovalofapplicableBDSprotocolsandreports

ManageChangeControlprocessanddriveimplementationof relatedtasks.

Providing SME support to the Manufacturing and Tech Services teams (inclusive of NPI projects for commercial product and new builds) which the company undertakes through project participation and QC readiness

Representing QC at product andtechnical team meetings and support all associated support activities

SupportingmanagementincontinualenhancementoftheQCstrategic plan

Drive process efficiencies and develop CI capability, using CI tools to drive and support improvements within QC with a particular focus on new technologies

Youwillneedtohave:

B.Sc.degreeinbiological/chemicalsciences,business,orotherrelatedtechnicaldegreeor equivalent experience in regulated industry

Preferable4-6years’experienceinqualitycontrol/cGMPQuality environment in a biotech, pharmaceutical or bio-pharmaceutical manufacturing environment

A high degree of technical competency in Chemistry and Biochemistry methos

Demonstratedabilitytosuccessfullycollaborate,influenceandleadinamatrixorganization

Excellentcommunicationandinterpersonalskills

Provenrecordindemonstratingagility

Experienceofinvolvementintechnicalissueresolution,inamultidisciplinaryenvironment

Wewouldpreferforyoutohave:

Experiencein writing of technical documents and investigations

Projectmanagementskills.

HighlevelofproficiencyinMSOfficesoftwareincluding:Word,Excel,Outlook,Visio,and PowerPoint.

Date Posted

26-Nov-2025

Closing Date

25-Dec-2025Our 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.

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