Senior QA Specialist

5 days ago

Dublin, Ireland Life Science Consultants (LSC) Full time

LSC have a great contract opportunity for a Sr QA Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 3+ years experience in Quality Assurance in a biotech manufacturing setting and are ready for your next challenge, this could be the perfect project for you ABOUT THE PROJECT - KEY RESPONSIBILITIES: Support the Qualified Person with the Batch Certification function Prepare and review batch documentation packages for QP release as per SOP requirements Liaise with Supply Chain and Quality colleagues to ensure that disposition lead times are consistently met Update SOPs, controlled documents i.e. FORMS and OJTs Assist in new product introduction activities as required Support the site inspection readiness program for corporate and regulatory inspections Identify and make recommendations for improvements to ensure continuous improvement Participate in site activities associated with the QMS (e.g. Change Control, Self-Inspections, Quality Agreement updates, Customer Complaints, Product Quality Record Reviews) as required ABOUT YOU - ARE YOUR SKILLS A MATCH? A degree in science, engineering or related discipline is essential. A minimum of 2 + years' experience in pharmaceutical /biopharmaceutical industry Experience using data or electronic document management systems (DCA, Trackwise, Infinity, and SAP) Strong working knowledge of Microsoft Excel and PowerPoint Ability to work on his/her own initiative in addition to working as part of a team Apply via this advert or contact Kathy Gillen on 0 if you have any more questions about this opportunity Applicants for our contract roles in Ireland are required to have a Stamp 1G or a Stamp 4 visa. LSC are unable to provide visa sponsorship.

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