-
Job Description
Senior Associate Quality Control NPI
Join an award-winning Pharmaceutical organization based in Dublin, contributing to the quality of tasks and services, and collaborating with a leading multinational to achieve excellence.
Key Responsibilities:
- QC Representative: Participate in NPI activities and routine product meetings, ensuring the quality of tasks and services.
- Plan, perform, and manage non-core testing related to NPI activities, including sample management and data analysis.
- Create and approve protocols, sample plans, SOPs, and documentation related to NPI QC activities.
- Coordinate method validation and transfers, ensuring readiness and compliance.
- Contribute to regulatory filings, lab investigations, and continuous evaluation of lab practices for compliance.
- Approve lab results, represent the department/organization on various teams, and interact with outside resources.
- Create APPX data files and randomization memos to facilitate data analysis.
Requirements:
- Bachelor's degree in a science discipline.
- Approximately 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
- Strong background in Chemistry and Analytical testing is required.
Skills: Quality control, NPI, Analytical Techniques