Senior QA Associate 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.
This role offers you a chance to work in a state of the art facility, within a people centred management structure and with a company that is grounded in the local community including various educational programs aimed at students in second and third level.
The QA Sr Associate will:
-Write, review and approve Standard Operating Procedures
-Provide Quality support for triage and investigation of non-conformances (NC’s)
-Review and approval of NC’s and CAPA’s for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
-Participates in customer complaint investigations as required.
-Provides training and advice to staff in order for them to perform their desired functions.
-Observe and provide real-time quality oversight, and support for warehouse, Supply Chain and Quality Control operations as required. Maintain the site reserve/retain samples program
The QA Sr Associate will require:
-University degree. Engineering or Science related discipline preferred.
-Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry
-Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
-Experience working in aseptic operations, protein formulation, vial and syringe filling.
Call Mairead in LSC on 0214777 329 to discuss this QA Sr Associate role in more detail or apply directly via this advert.