LSC have a great contract opportunity for Device Quality Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Support the development of the Design Development Plan in line with applicable regulations for combination products including Planning, Design and Development, Design Verification, Design Validation, Technology Transfer and Risk Management.
- Support documenting and periodic review of supplier quality requirements and supplier quality agreements.
- Partner with Quality Scaled Digital Services (QSDS) to ensure successful deployment of a combination product Quality Management System.
- Support risk assessments relating to batch release or product quality for clinical and commercial products.
- Supports Notified Body and Health Authority inspections and compliance.
- Ability to work cross functionally with Development, Tech Ops, Regulatory Affairs, Quality Assurance.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- B.Sc. / B Eng degree in Engineering or Science or equivalent experience in regulated industry.
- Knowledge of the regulatory and compliance requirements of design control for medical devices and/or combination products (e.g., FDA QSR 21 CFR Part 4 and 820 / ISO 13485 and Regulation (EU) 2017/745).
- Preferable 4 years +' cGMP experience within quality in a medical device, combination product R&D or manufacturing environment, ideally clinical phases through commercial
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 LSC on 021-4777329 if you have any more questions about this role!