LSC have a great contract opportunity for a 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.
If you have 4+ years of experience working in the pharmaceutical, medical device, or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Support the Medical Device Quality Team in managing combination product quality records and document management activities.
- Support change control, CAPA, deviation, and Quality Management System (QMS) processes.
- Coordinate quality governance activities, audits, inspections, and management review reporting.
- Ensure quality records are processed and maintained in compliance with company procedures and regulatory requirements.
- Partner with cross-functional teams and external suppliers to support combination product quality and compliance.
- Support continuous improvement of the combination product Quality Management System.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree or equivalent experience in a regulated industry.
- 4+ years' cGMP experience within Quality in a medical device, combination product, or pharmaceutical environment.
- Experience with Quality Management Systems, CAPA, Change Control, electronic QMS/document management systems (e.g. Veeva Vault), and medical device regulations including ISO 13485 and FDA 21 CFR Part 820.
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 Jenny Murphy at LSC on 021 4777329 if you have any more questions about this role!
