QC Specialist NPI

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.