Sr QC Specialist (NPI) 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 QC Specialist (Senior) will:
o QC Representative for site / laboratory upgrade projects
o Plan and manage QC related activities from site projects.
o QC Representative for NPI activities and routine Product meetings
o Plan and Perform non-core testing related to NPI activities
o Manage all sample management activities related to NPI activities throughout the site Sample shipments and temperature monitoring activities for NPI activities
o Create/own and approve protocols, sample plans, SOP and documentation related to NPI
o Responsible for their own training and safety compliance.
o Assist with resource management, QC Project Management and other work streams as required by the lab management.
o Authoring, executing and documenting the qualification of existing laboratory equipment in a cGMP regulated environment. Writing equipment validation protocols and associated summary reports.
The QC Specialist (Senior) will require:
o Bachelor’s degree in a Science related field is required.
o 8+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
o Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
o Need to have: project management, equipment validation, NPI,extensive testing from an NPI perspective
o Ideally would have significant experience with setting up new labs.
o The work across multiply projects 1) Intensive testing 2) Facility upgrade
Call Amparo in LSC on 0214777 329 to discuss this QC Specialist (Senior) role in more detail or apply directly via this advert.