LSC have a great contract opportunity for an External Quality 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.
If you have a Bachelor of Sciences in Physical/Engineering/Chemical /Biological and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Assist with quality oversight of the supply chain, manufacture and packaging of products in various Contact Manufacturing Organizations.
- Review of Manufacturing/Packaging batch records and Quality Control documentation prior to recommending final batch release.
- Review and approve standard operating procedures, master batch records and product specifications.
- Provide Quality oversight of deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
- Proactively support the continuous improvement of quality systems by identifying and building in efficiencies from a systematic and compliance perspective.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A minimum of 5 years' experience in a cGMP regulated FBDS, drug product manufacturing and/or packaging environment is a pre-requisite for application, with exhibited knowledge or proficiency in Quality Assurance and Compliance
- Ability to comprehend technical information related to equipment, manufacturing processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
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!
Apply via this advert or contact Pawel Jurkiewicz at LSC on 021-4777329 if you have any more questions about this exciting opportunity!