QC Specialist 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 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 Provide regulatory filing support for activities associated with method transfer/method validation
o Project Manage the overall Analytical Product Transfer Plan for QC.
The QC Specialist will require:
o Bachelor’s degree in a Science related field is required.
o 6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry
o 2 – 3 years of specific method transfer experience is desirable. Experince as Technical leader /Project manager with proven track record
o Experience in Organisational Change/ Change Management preferred
Call Amparo in LSC on 0214777 329 to discuss this QC Specialist role in more detail or apply directly via this advert.