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.
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 will:
o Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
o Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities.
o Relocation of existing equipment to new Chemistry laboratory.
o Development of laboratory equipment specifications to be used for procurement of new laboratory equipment and instruments.
o Writing equipment validation protocols and associated summary reports.
o Maintaining a current working knowledge with regard to regulatory requirements for equipment qualification and calibration.
The Sr Associate QC will require:
o 3rd level degree in a relevant discipline
o 3 years solid GMP pharma experience
o Experience and comfortable with general GMP IS systems, electric lab notebook, QMTS, LIMS.
o Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
o Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Call Amparo in LSC on 0214777 329 to discuss this Sr Associate QC role in more detail or apply directly via this advert.