Sr Associate QC (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.
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 Sr Associate QC (Senior) will be responsible for:
o Ownership, accountability and provision of Analytical Transfers, NPI and Subject Matter Expertise for key process and associated documentation.
o Leading the QC project team and demonstrating the ability to positively influence others
o Creation of Analytical transfer plans, protocols and reports
o Creation of Analytical validation plans, protocols and reports
o Co-ordination of materials and critical reagents
o Authoring and creation of analytical methods, SOP’s and risk assessments.
o Support data verification and data appendices
o Provide regulatory filing support for activities associated with method transfer/method validation
o Project Manage the overall Analytical Product Transfer Plan for QC.
The Sr Assocaite QC (Senior) will require:
o Bachelor’s degree in a Science related field is required. (Engineering, Science or technology )
o Highly skilled in MS Office, MS Project, PowerPoint.
o Visio experience preferable
Call Amparo in LSC on 0214777 329 to discuss this Sr Associate QC (Senior) role in more detail or apply directly via this advert.