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QA Compliance Specialist

Employer
Team Horizon
Location
Dublin
Salary
Competitive
Closing date
8 Jun 2023

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Sector
Biomedical Science
Role
Specialist
Contract Type
Contract
Team Horizon is seeking a QA Compliance Specialist for a 12 Month FTC for our Cork based Client, who a global biotechnology company with a large presence here in Ireland. In this role you will contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations and have primary responsibility for the quality assurance compliance activities Why you should apply: There is a culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people s lives. What you will be doing: Implementation, maintenance and development of QA systems Reviewing the GMP documentation e.g, SOPs, reports, methods, specifications, validation protocols, quality contracts etc., and Exceptional Documents e.g. NCRs/PNCRs, Planned Deviations etc. Writing and reviewing QA department procedures and reports e.g. protocols, SOPs, environmental reports etc. Reviewing and Approving other departmental procedures and reports. Internal Auditing (when required) of FLI Departments and external auditing (when required) of Material and Service Suppliers (including Supplier Management). Alerting the QA Compliance Manager in case of detection of a discrepancy / non–compliance. Assisting in the preparation and reviewing of QA department reports and metrics e.g. monthly quality report, discrepancy reports, exceptions reports, KPI reports. Reporting and communication to QA Compliance Manager on key events and issues etc. via normal in house reporting structure e.g. meetings, formal reports etc. Participate in initiatives and action plans for the development of QA and improvement of GMP compliance. Participating and follow–up the audits and/or inspections carried out at the site by the authorities or clients Address regulatory requests from both internal and external customers. Any other duties as assigned What you need to apply: Bachelor s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) Ideally, you would have a technical background and understanding of the audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance. Proficient in Microsoft Word & Microsoft Excel Excellent written and oral English communication skills

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