We are looking to recruit a Senior Quality Specialist to join our expanding team. The position is permanent and is site-based in our Headquarters, in Little Island, Cork. The vacancy comes at a crucial stage in the company’s continued growth; the successful candidate will play a key role in the continued and future growth of the company going forward.About the RoleReporting to the Quality Lead, this position requires an effective collaborator to work cross-functionally and as part of a team. With a strong focus on supplier and customer management, this role will facilitate continuing compliance with the QMS. Working in an ISO-certified environment, CPi endeavours to excel by also matching cGXP guidelines through shared ownership and execution of the QMS. This role is key to maintaining the quality and safety of products for the bio/pharmaceutical market, ensuring the company meets the specification requirements of its multinational customers, and assuring the security of the supply chain and the company’s interests.Key ResponsibilitiesInvestigation and documentation of non-conformancesDrafting and timely execution of actions for Change Control and CAPAUpdate of key tracking tools for QMSBatch Record Review and material release (includingCoA) to ensure compliance with GMP requirementsQA Review and Approval of SOPs, Work Instructions, and FormsCustomer, supply chain notification activitiesExecution of internal and external auditsProduct release activitiesContribution to improving KPI metricsExperience & Qualifications3-5 years + in a Quality function in a GMP/regulated environmentBio/Pharmaceutical, Medical Device, Nutraceutical, or Food Science backgroundGraduate with a scientific degree or qualifications in science, engineering, or technologyDirect exposure to customer/regulatory auditsPrior experience of system ownershipCompetitive salary and benefits packageOpportunities for career advancement in a rapidly expanding company.A dynamic, supportive work environment with a focus on professional growthIf you’re a self-motivated, detail-oriented individual with a desire to contribute to the growth of an innovative Irish biotech company, we encourage you to apply today.To apply for this position, please complete the form below and upload your CV and cover letter.
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