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.
•Under minimal supervision, responsible for one or more of the following activities in QC including HPLC, CE, GELs, analytical testing, characterization, method transfer, sample and data management and equipment maintenance.
• Contributes to team by ensuring the quality of the tasks/services provided by self.
• Contributes to the completion of milestones associated with specific projects or activities within team
• With a high degree of technical flexibility, work across diverse areas within the lab.
• Plan and perform routine analyses with efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/ verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
• Experience in a wide variety of analytical techniques including but not limited to HPLC, Capillary Electrophoresis, UV, FTIR, suv -vis particle testing.
Education & Experience
• Bachelor’s degree in a science discipline.
• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
•Experience with HPLC, CE, GELs, analytical testing, characterization, method transfer, sample and data management and equipment maintenance within GMP/ GLP enviroment
• Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.