A QA Specialist is required by a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
As QA Specialist you will:
o Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for biologics facility.
o Review and approval technical support documentation. (Examples include cleaning, process, method validation).
o Review and approval of manufacturing batch records.
o Provide quality support for implementation of new product on SAP.
o Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained /controlled.
o Provide QA support for risk based verification activities. Review and approval equipment/utilities verification documentation from design to post execution.
o Review and approval of functional area documentation
o Authoring, review and approval of QA-related procedures.
o Oversee the effective documentation and tracking of quality management system activities including deviations and change controls, CAPA.
o Review and approval of validation documentation for the MES System.
o B.Sc. in science/engineering with a minimum of 4 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
o Min 4 years QA experience in a pharmaceutical manufacturing 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 Previous experience with MES.
For full details on this role please contact Kathy Gillen on 021 4777329 or apply directly through this advert.