Job Title:
Associate - QA Materials Management
About Us:
Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals.
Main Purpose and Objectives of the Position:
* Provides Quality leadership, direction and governance for materials management.
* Assures consistent implementation of standards across the quality system.
* Manages quality-related matters specific to Material Operations.
Key Responsibilities:
1. Develop and implement Quality system for materials management including SOPs, Quality agreements and risk assessments.
2. Review and approval of change controls, deviations, failure investigations, product quality complaints associated with the area(s) of responsibility.
Basic Qualifications:
* BSc, M.Sc., or PhD in Science, Engineering, or related discipline with appropriate experience.
Additional skills/experience:
* Minimum of 5 years' experience in GMP operations.
* Strong understanding and working knowledge of local and international data integrity regulations, data quality management, data security and other policies/regulations as applicable.
This role requires strong technical expertise in areas of cGMPs e.g., QC and manufacturing operations, production practices, and quality systems including maintenance processes. The ideal candidate will have a positive influence on the team, be a relationship builder, and have strong communication skills. This role also involves decision making and being decisive for the benefit of the team.