A QA Validation Specialist is required for a 6 month contract, working onsite at LSC’s major biopharma client based in west Dublin. This is a key role providing site wide QA activities to support the start up activities of the bulk drug substance manufacturer.
As QA Validation Specialist you will:
o Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
o Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. 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) computer system validation deliverables.
o Review and approval of engineering 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 and CAPA.
-BSc. in science/engineering with a minimum of 5 years QA experience in a pharmaceutical -manufacture/biopharmaceutical environment.
-Strong process knowledge to include upstream and/or downstream processing.
-Bulk Drug Substance experience is essential.
Call or email Kathy on 021 4777329 / email@example.com for futher info on this and other QA and Validation roles.