LSC have a great contract opportunity for Quality Assurance Validation 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:
- Provide QA support for Risk-Based Verification (RBV) and Computer Systems Validation (CSV) activities in the capacity of Quality Assurance Subject Matter Expert.
- Review and approval equipment/utilities verification documentation from design to post execution.
- Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
- Review and approve Validation protocols / reports as required.
- Provide quality support for serialization of Finished Products
- Support the vendor quality management program including generation and review of Quality Agreements
- Leading actions assigned to College Park from complaints process
- Provide QA and compliance support to projects, including NPIs, for Alexion Dublin packaging activities.
- Review and approval of functional area documentation (SOPs, Packaging Instructions, Work Instructions, technical protocols and reports)
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 Paul O Driscoll at LSC on 021-4777329 if you have any more questions about this role!