LSC has a fantastic opportunity for Project Quality Assurance 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:
- Provide oversight and management of PQA input into all design deliverables including, where applicable - Drawings, Datasheets, specifications and Engineering Lists.
- Lead GMP reviews on behalf of client, at 30%, 60% and 90%, manage and close all actions generated from GMP reviews.
- Organize PQA support for all Turnover package reviews, both Vendor and Contractors. Align with CQV in relation to documentation deliverables for Vendor Data Requirements (VDR) and Table of Content (TOC).
- Aligning with CQV and Construction on System boundaries and have input into review exercise.
- Quality SME for all Project and CQV related questions and queries.
- Aligning with CQV team requirements, build and manage PQA Team for the duration of the Project, both planning and costing for entire team.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Ability to keep work pace and meet deadlines. Good organizing and planning skills.
- Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
- 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 Grainne Hodnett at +353 214771329 if you have any more questions about this opportunity!
