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:
- Manage Project Quality Assurance (PQA) activities to support QC engineering project covering all workstreams
- Create, approve and maintain PQA Plans and procedures for the project to cover all aspects from conceptual design, through to final Blue Tag Handover
- Align with CQV Project Manager on CQV process to be utilized on Project. With consideration given to ASTM E2500, Grouping, Family Approach and Leveraging from FAT-IOQ
- Lead PQA through all vendor assessments relating to all direct impact vendors. All action from assessments will be tracked to closure.
- Oversight and management for PQA review and approval of all CQV generated documentation
- Provide oversight and management of PQA input into all design deliverables including, where applicable - Drawings, Datasheets, specifications and Engineering Lists.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Solid experience and minimum of 10 years of Biotech QAV experience including design and construction projects for biopharmaceutical manufacturing facilities.
- Strong leadership experience and project experience - knows how to set the direction for the project in regards of quality.
- SME on all Quality and Compliance issues - minimum 10 years
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!