Quality Assurance Specialist III 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.
As Quality Assurance Specialist III you will:
o Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to manufacturing and product supply.
o Acts as quality point person, providing guidance and feedback on quality assurance issues.
o Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
o Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups.
o Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and material movement (including cold chain) for both clinical and commercial products.
o Ensure relevant QA documents and procedures are approved to schedule to support technology (external and internal) transfers and new product introductions.
Education and Experience:
o B.Sc. in science/engineering with a minimum of 6-9 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
o Min 3 years QA experience in a pharmaceutical manufacturing environment, preferably in a biopharmaceutical environment.
o An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
o Excellent communication & presentation skills are essential.
o Excellent time management organizational skills along with a proven ability to multi-task.
o Preference strong deviation experience and some validation experience.
Call Mairead on 021 4777329 for full details of this exciting opportunity.