QC Sterility Specialist
6 days ago
LSC have a great contract opportunity for a QC Sterility Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have a minimum of 5 years experience in a cGMP Quality environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Work closely with CQV and Isolator vendor to perform all tasks associated with cycle development and cycle performance qualification.
- Develop and execute sterility related studies e.g. B&F, VHP residue and VHP ingress studies
- Develop and perform validation/verification of sterility test methods and processes.
- Implement and maintain the sterility testing program within the QC Micro Lab.
- Technical report writing in support of method verifications and routine testing.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree in Science/ Microbiology or related science.
- Experience in qualification of a sterility isolator required
- Minimum of 3 year's experience in Sterility testing (Membrane Filtration and Direct Inoculation) of sterile drug product and sterile pharmaceutical /biopharmaceutical products.
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 Peter Cronin at LSC on 021-4777329 if you have anymore questions about this QC Lab Support Validation Engineer opportunity!