LSC have a great contract opportunity for a Compliance Specialist to join a leading biotech company based in Dublin
If you have 5 years' experience in an FDA / EMA regulated environment, ideally in Quality Assurance, Quality Control, Operations or Technical Operations and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes.
- Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones.
- Support implementation and training for site Quality Systems and site GMP readiness activities.
- Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation.
- Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Previous experience in SAP Master Data build and maintenance
- QMS development and maintenance.
- Previous experience in Deviations and Change Control, participating in investigations and problem solving.
- Strong attention to detail and precision in preparing and reviewing GMP documentation.
- Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc. or similar
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 on 0214777329 if you have any more questions about this exciting opportunity!
