Senior Quality Assurance Specialist is required for a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. In July 2015 the site opened a $300million investment, which added significantly to the sites laboratory, filling, packaging and distribution (including cold chain) capabilities. The site is a fast paced, collaborative, team based working environment, where you get an opportunity to work with other highly skilled staff in a strategically important site in the companies global supply chain.
The Quality Assurance (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.
The Senior Quality Assurance Specialist will require:
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.
Call Mairead in LSC on 0214777 329 to discuss this Senior Quality Assurance Specialist role in more detail or apply directly via this advert.