LSC have a great contract opportunity for QA 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 minimum 3-5 years relevant experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in Quality Assurance and Regulatory Compliance and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide QA support to the site for drug substance GMP operations (Warehouse/material operations, Upstream/Downstream and Support Services manufacturing, Automation and Process Engineering, MES, QA Validation and Capital Projects)
- Participate within inter-departmental and cross-functional teams to immediately address issues in real time
- Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation, and corrections
- Support lot release activities/schedule including preparation of BDS/FBDS lot files
- Daily presence and support in the process teams and on the manufacturing, floor including walk-through of process issues and RCAR support
- Release of Raw Materials for drug substance production
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Demonstrated experience in supporting manufacturing operations, batch record review, MES and deviation/CAPA is highly desirable.
- Experience with batch release activities is an advantage
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
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 opportunity!