LSC has a fantastic opportunity for Sr. QA Automation Engineer 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:
- Ensuring the GAMP 5 requirements are met.
- Have input into QA Plan for project to cover all aspects from detailed design, through to final handover.
- Align with the Automation and CSV leaders on the project plans and approach with consideration given
- to ASTM E2500, towards testing for all Systems, from FAT-IOQ
- Support vendor assessments relating to all embedded software direct impact equipment vendors.
- Support the scope of all Computer System Validation Qualification efforts to be implemented for the Project GMP Systems.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum of 5 years of experience implementing and supporting QA CSV scope and liaising with Automation on Pharmaceutical Projects.
- SME on Quality and Compliance issues
- Working knowledge of ASTM E2500 / Leveraging Verification process
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 Paul O Driscoll at +353 214771329 if you have any more questions about this opportunity!