LSC have an great opportunity for an experienced QA Specialist to work with our multinational biotech client based in Athlone to provide quality and cGMP input and oversight for all start-up project activities through commercial readiness.
QA responsiblities will include:
o Provide QA support for risk based verification activities. Review and approval equipment/utilities verification documentation from design to post execution.
o Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
o QA support for implementation of Manufacturing Execution System (MES) and development of batch records.
o Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
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 approve Validation protocols as required. (Examples include cleaning, process, method validation).
Experience and education requirements:
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 4 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.
Please contact Regina on 021 4777329 for full details on this role or apply directly through this advert.