Sr 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 Sr Quality Assurance Specialist 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
The Sr Quality Assurance Specialist will require:
o University degree gained in Chemistry, Biology or Science related discipline.
o Relevant experience (5yrs +) 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 Excellent written and verbal communication skills
o Proficient in the use of systems; SAP, QMTS, Efinity, EDMQ and SM-LIMS, Maximo
o Experience working with raw material suppliers
Call Mairead in LSC on 0214777 329 to discuss this Sr Quality Assurance Specialist role in more detail or apply directly via this advert.