LSC have a great contract opportunity for a QA CMO Associate to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long term market support. The team on site grow, purify, formulate and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
The QA CMO Associate will be responsibe for:
o Assist with the oversight of the supply chain, manufacture and packaging of the companies 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.
o Proactively support the continuous improvement of quality systems by identifying and building in efficiencies from a systematic and compliance perspective.
o Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.
The QA CMO 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 5 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Regina in LSC on 0214777 329 to discuss this QA CMO Associate role in more detail or apply directly via this advert