QA Technical Specialist

IrishJobs

Dublin, Dublin, Ireland

Dublin, Dublin, Ireland

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About

Your new company At Hays Specialist Recruitment, we have a great opportunity for a QA Validation & Technical Operations Specialist to join our Biopharmaceutical client in Dublin on an initial 12-month contract. Your new role Quality Oversight for new product introduction in a Bulk Drug Substance facility. Quality oversight for new or modified facilities, equipment, technologies, including analytical, as well as other continuous improvements and reclassifications. Site QA responsibility is to provide technical expertise for all QA and compliance topics / issues relating to the Alexion manufacturing Facility. Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, Equipment and others. Review and approval of qualification/verification/validation documents for facilities, equipment, processes, analytical methods, suppliers, software and others. (e.g. URS, Facility, Utility, IT Systems, Test Methods, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures. What you'll need to succeed A minimum of 6-8 years relevant experience within the pharma industry or a related field. Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes is strongly desirable. Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. Excellent accuracy and attention to detail What you'll get in return What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career. Hays Ireland is a trading division of Hays Specialist Recruitment (Ireland) Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be Benefits: 12-month Contract

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Dublin, Dublin, Ireland

Languages

English

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