LSC has a fantastic opportunity for CQV Lead to join an advanced global team in Denmark that promotes self-development, encourages collaboration, and fosters a learning environment. The company specialises in clinical & commercial manufacturing of Biotech medicines, including viral gene therapies and has built a strong reputation over the years for bringing complex and lifechanging therapies into reality. This is a chance for you to be a part of a fast-growing, multicultural company that has a compelling vision for shaping the future of medicine.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Lead the Commissioning, Qualification and Validation of QC Lab and Warehouse systems.
- Ensure Commissioning readiness of all Systems to support Equipment Start-up and IOQ Testing.
- Conduct FAT/SAT activities aligned to the current equipment vendor during installation and readiness.
- Liaise with all Project Groups to ensure all Systems are managed appropriately for the Project Lifecycle.
- Liaise with CQV Document Generation Lead in relation to generation and approval of assessments, reviews and protocols.
- Support execution of all LSCC CQV deliverables; IOQ, field execution
- Generate and ensure timely approval of all Commissioning and IOQ Final Reports.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 10 years' experience including experience with design and construction projects for QC Lab / Warehouse facilities.
- Experience with complex projects.
- Experience within generation of VPPs, risk assessments, and qualification protocols.
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 Sarah Ninan at +353 214771329 if you have any more questions about this opportunity!
