Our client, a large multi-national bio-pharmaceutical company in Dublin are seeking a Work Cell Specialist to join their growing team on a permanent basis. The company who operate internationally, manage a diverse portfolio of multi-site CMO's, and are looking for the right individual to provide information insight and data analysis, while driving execution of transactional/tactical tasks to ensure the CMO work cell success for the organisation.
The Role
Responsibilities will include:
- Ensuring accuracy and completion of data entries
- Working on Quality records and contractual needs for the company
- Owning of NC.Class records, CAPA, CAPA EV, and more complex change control records
- Successfully managing relations with multi-site CMO representatives
- Reporting on contract site performance metrics to site lead
- Identifying opportunities to continuously improve site performance
- Managing timeline of Technical Transfer
- Coordinating risk management activities as part of each transfer
The Person
- Bachelor's in Business Administration, Engineering or Science-related field
- 5+ years' experience in protein, API, DS, DP or packaging manufacturing environment
- 5+ years' in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
- 2+ years' project management experience leading multi-functional and/or multi-location team
- 1+ years' experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
Apply now or to find out more contact me directly on 01-632 1886 for a confidential discussion.
