Senior QC Systems Validation Associate
Hybrid
RK5205
Contract 12 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



This position will be responsible for performing activities towards the design, configuration, and validation of the new ELN system, recreation and/or migration of required master data, and involvement in deployment of production instances at the site.





Key Responsibilities:

• Participate in process engineering activities
• Facilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflows
• Participate in system requirement, software configuration, and design activities
• Receive and/or verify master data for the site(s)
• Coordinate ELN Template development and review with site SMEs
• Support the development and review of Operational Qualifications
• Execute User Acceptance Testing & Data Migration Verification
• Review and provide input on training materials
• Support training material development by providing inputs and reviews
• Support site Instrument Qualification activities such as planning and execution

• Bachelor’s degree and 3 years of industry Quality Control or Quality experience
• GxP experience, specifically practices and requirements in the testing of biopharmaceuticals.
• Experience in development and validation testing of software used in a GMP environment.
• Experience and knowledge in using electronic lab notebook systems and inventory management systems (Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.).
• Experience in the use of other industry systems such as Veeva & Empower.
• Experience in testing or with processes involving analytical methods.