Sr Associate QC 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 Associate QC will:
o With a high degree of technical flexibility, work across diverse areas within the lab
o Plan and perform routine analyses with efficiency and accuracy.
o Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
o Report, evaluate, back-up/archive, trend and approve analytical data.
o Troubleshoot, solve problems and communicate with stakeholders.
o Initiate and/or implement changes in controlled documents.
o Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
o Write protocols and perform assay validation and equipment qualification/ verification.
o Introduce new techniques to the lab, including method transfers, reports, validations and protocols. o Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
o Approve lab results
The Sr Associate QC will require:
o 3rd level degree in a relevant discipline
o 3 years extensive HPLC experience with Empower software
o Peer to peer review experience
o 3 years solid GMP pharma experience
o Experience and comfortable with general GMP IS systems, electric lab notebook, QMTS, LIMS.
***Potential for shift cover***
Call Amparo in LSC on 0214777 329 to discuss this Sr Associate QC role in more detail or apply directly via this advert.