LSC requires a Senior Quality Assurance Specialist for a South Dublin based Biopharmaceutical company.
The QA Specialist is a senior and active role within the broader QA function. The QA Specialist will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
QA specialists will be required to understand and grasp a broad range of quality related competencies. In addition to routine Quality Assurance duties, QA Specialists may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within the site, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.
Education and Experience:
-University degree. Engineering or Science related discipline preferred.
-Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
-Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
-Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
-Experience working in aseptic operations, protein formulation, vial and syringe filling.
PLEASE NOTE: This role includes Shift: 2 Cycle (8 hr days and evening rotation)
Call Evelyn in LSC on 021 4777 329 to discuss this Senior Quality Assurance Specialist role in more detail or apply directly via this advert.