LSC have a great contract opportunity QC Manager 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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Coordinate effective planning and execution of projects related to Microbiological methods/ Technology
- Ensure timelines are managed effectively
- Ensure consistent delivery to stakeholders and effective communications
- Provide Technical expertise to QC and external teams
- Assist in trouble shooting and optimisation of methods
- Coach and develop individuals within the team
- Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents
- Ensure the team is compliant to GXP and safety and environmental standards
- Conduct and document out of specification / out of trend result investigations
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
- Lead and implement initiatives that add value to the QC and site operations
- Deliver on capital/budget
- Scope out future efficiencies/ optimization opportunities
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 Cathal Rourke at LSC on 021-4777329 if you have any more questions about this opportunity!