QA Associate for the CMO group is required for a Cork based Biopharmaceutical company.
It is a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
The Quality Assurance Associate reports to the QA CMO Lead, and is responsible for supporting quality systems, assisting with the batch release process of drug substance; bulk drug product and pack label orders produced by external Contract Manufacturing Organizations for a range of Small Molecule and Biologic Products.
This role offers you a chance to work in a state of the art facility, in an innovative Biotechnology company, with excellent career development opportunities and a clear and committed patient focus.
The QA Associate will:
o Assist with the oversight of the supply chain, manufacture and packaging of products in various Contact Manufacturing Organizations.
o Review of Manufacturing/Packaging batch records and Quality Control documentation prior to recommending batch release.
o Review and approve standard operating procedures, master batch records and product specifications.
o Provide Quality oversight of deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
The QA Associate will require:
o Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
o A minimum of 2-3 years’ experience in a cGMP regulated drug substance, drug product manufacturing and/or packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
o Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
Call Regina in LSC on 0214777 329 to discuss this QA role in more detail or apply directly via this advert….