We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. 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.
The position is in the Biochemistry and Early Development Stability Sciences Team in the Analytical Development Department. The successful candidate will join to the Analytical Development Empower Team with the below duties and responsibilities.
Main duties and responsibilities
• Ensure that EHS standards are always met on site, adhering to appropriate PPE and COVID-19 measures and guidance
• Day to day systems support, ensuring that E-tickets are addressed in a timely manner
• Design and development of custom fields
• Build, Design, and release of Empower report methods/projects
• Manage and control Separations data (RRM, Sample) within Empower
• Providing technical support for Investigations and data requests as required
• Authoring and review of Strategy documents
• Validation Support for installation and qualification of new Lab equipment
• Participate/Lead in Laboratory investigations as applicable
• Escalation of Laboratory issues to team lead in a timely fashion
• Perform other duties as designated by Team Lead
• Take an active role in Continuous Improvement, identify and drive improvement initiatives.
Education & Experience
• A BSc, MSc or PhD in Biotechnology, or a related scientific field.
• Minimum of 3yrs experience using Empower Software
• Development/ Administrative experience is desirable
• Experience with Change Management systems
• Acute attention to detail with focus on Data Integrity
• Familiarity of regulatory requirements for E-Systems and Separations technology (HPLC, CSDS, CIEF, UPLC)
• Efficient, flexible with excellent communication skills and ability to work well within team structures
• Experience in C&Q, and Process validation
• Experience in direct interactions with regulatory agencies during site inspections