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Qc new materials & change control specialist

Carlow
PE Global (UK)
Posted: 20h ago
Offer description

PE Global is currently recruiting for QC Associate Specialist for a leading multi-national Pharma client based in Carlow.This is a contract position.Role:You will support all aspects of New Material Introduction process and associated supplier changes ensuring effective interaction with other departments/global teams on matters related to new material introduction and associated qualification as well as support selection and management of external testing Laboratories ensuring all outsourced methods are validated and suitable for the product/material required.Responsibilities:Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLPFacilitate and drive effective communication to ensure success through representation of QC team on tier meetingsSupport all aspects of New Material Introduction process ensuring effective interaction with other departments/global teams/ external contract testing labs on matters related to new material introduction, supplier changes and associated qualificationParticipate and support Internal/External InvestigationsCoordinate the creation/ update to Quality standards for raw materials and components at Carlow. Complete impact assessments for change controls related to Carlow processesCoordinate any efficiency/ increased Lab capability projects as detailed by Quality Control ManagerProvide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibilityCoordination, ownership, and author as required for Annual Product ReviewParticipate in Quality Risk ManagementRequirements:Bachelor’s degree or higher preferred; ideally in Chemistry, analytical chemistry or a related Science discipline or relevant experience2-4 years of experience in a cGMP laboratory environmentsKnowledge of or previous experience in New Material Introduction processProficiency in Microsoft Office and job related computer applications requiredGood communication, interpersonal skills and ability to work across teamsDemonstrated ability to drive the completion of tasksDemonstrated ability to solve problems/perform investigationsMethod validation and method transfer experience would be advantageInterested candidates should submit an updated CV.Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@peglobal.net***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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