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Details

Associate Scientist/Analyst NPI


Reference:JSC0007261 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Scientist

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.

Duties


•Reporting to the QC NPI Manager, this position is responsible for delivery of the NPI and Commercial Product Portfolio projects to QC
• Co-ordination and project management of Clinical product introduction to QC
• Acts as a Single Point of Contact for introduction of new products and/or technologies to QC
• Participate in Site NPI teams, attend Work Cells
• Collaborate with global and local stakeholders in Analytical development, Technical Operations, QC & Operations
• Investigating and resolving challenges relating to Method Transfer activities in QC
• Participate in/lead Cross Functional activities with JSC NPI teams/AD/QC
• Co-ordination, Support of Co-validation/PPQ activities
• Completion of assigned tasks to support the introduction of testing associated with new or existing projects
• Authoring/Review/Approval of documents associated with NPIs or Commercial product lifecycle management and analytical method transfer in QC
• Deputise for QC NPI manger where appropriate

Education & Experience

• A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
• Proven experience of leading projects involving multiple stakeholders
• Experience/understanding of the Analytical Method Transfer process
• 4-6 years of relevant experience working in a laboratory setting within a GMP regulated environment
• Proven experience of leading projects involving multiple stakeholders
• Experience with Regulatory filings
• Experience of Microsoft Word, Excel and Outlook
• Experience in eLIMS, TruVault and/or other business systems
• Problem solving/decision making methodology training