LSC require an experienced Quality Assurance Validation professional to work on a multimillion dollar Biotech facility based in Dublin. Our client is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
This role will be responsible for delivery of QA Validation activities at this Bulk Drug Substance Facility from start up through to commercial readiness to ensure commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements.
This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.
As QA Valiidation Specialist you will:
o Provide quality and validation cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
o Provide QA validation 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 validation 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, and batch disposition.
o Review and approve Validation protocols as required. (Examples include cleaning, process, method validation).
You will have:
o B.Sc. in science/pharmacy 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 Kathy on 021 4777329 for full details of this role or apply directly through this advert.