Quality Assurance Specialist is required by a biopharmaceutical company based in Westmeath. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
The Quality Assurance Specialist will be responsible for:
o Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to manufacturing.
o Acts as quality point person, providing guidance and feedback on quality assurance issues.
o Ensure relevant QA documents and procedures are approved to schedule to support technology transfers and new product introductions.
o Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
o Review and approval of Change control activities to ensure any impact on GMP is appropriately assessed.
o Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.
o Supports review and approval of quality control documentation for the release of materials on site. Provides oversight of contract laboratories, as required.
o Review and approval of manufacturing batch records to support QP release of drug product.
o Third level qualification e.g. B.Sc. in science/pharmacy.
o A minimum of 3 years relevant experience within the pharma industry or a related field.
o Strong knowledge of cGMP requirements for pharmaceutical manufacturing required.
o Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
o Good knowledge of relevant computer packages e.g. Trackwise or similar
o Technical writing skills required.
Call Mairead at LSC on 021 477329 for more information on this QA Specialist role, or apply directly via this advert.