Quality Assurance Specialist (senior) 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 Specialist (senior) will:
o Responsible for the review and disposition of incoming materials and components
o Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause
o Provide QA oversight for Supply Chain and QC
o Own or provide QA oversight for non-conformance records, CAPA records and change control records
o Manage the Raw Material reserve samples
o Collaborate with Global IQA and SQM networks to drive alignment and continuous improvement within the organisation
TheQuality Assurance Specialist (senior) will require:
o University degree gained in Chemistry, Biology or Science related discipline.
o 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.
o Proficient in the use of systems; SAP, QMTS, Efinity, EDMQ and SM-LIMS, Maximo
o Experience working with raw material suppliers
o Understanding/experience with NC/CAPA system, Change Control Management System, and Documentation Systems
Call Mairead in LSC on 0214777 329 to discuss this Quality Assurance Specialist (senior) role in more detail or apply directly via this advert.