LSC have a great contract opportunity for a QO systems specialist 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 3rd level qualification (Degree/Diploma) in Chemical systems / IT QC Laboratory systems or a related discipline and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Actively leads and supports QO Systems / QC Projects as required with responsibility for the system full lifecycle from design, development, implementation, maintenance, and decommissioning of QC Laboratory Systems (simple (no data) to complex (data) with the approval of deliverables associated:
- Change Controls, Plans, Specifications, Configuration set up, Protocols including execution of qualifications and method setup
- Assessments completion including ERES, ALCOA, Audit Trail Assessment, Security
- Reports including Validation Reports
- SOPs updating and training
- Periodic Reviews, Access Reviews
- Calibration/PC Schedules, Repair and Maintenance
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Knowledge of cGMPs and appropriate regulatory requirements.
- Highly skilled in Technical Writing to Audit Standard.
- Flexibility to multitask
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 QO systems specialist opportunity!