- Provide Process Descriptions and Facility Fit Comparisons.
- Assess manufacturing requirements prior to the transfer of processes into new manufacturing facilities.
- Assist in the writing and review of manufacturing/batch records, and SOPs if necessary.
- Provide manufacturing descriptions and technical evaluations for master files.
- Gather, trend, and analyse process generated data
- Generate process evaluation reports and process transfer documentation from Master File Data.
- Provide technical support to improve understanding of the responsibility of contract manufacturer
- Ensure all tasks are performed within cGMP guidelines.
- Support Technical Agreement implementation
- Build process knowledge repository/database
- Arrange support when necessary during manufacturing operations.
Required Education / Experience / Knowledge / Skills
- BS Life Sciences or Engineering with 1+ years of experience.
- Ability to communicate clearly the timelines and important milestones.
- Ability to adapt to a quickly changing environment.
- Knowledge of cGMP and other applicable regulations.
- Ability to effectively communicate issues and ideas with peers and with management.
- Ability to facilitate meetings with cross-functional teams.
- Excellent interpersonal, written, and oral communication skills.
- Ability to build effective working relationships throughout the organization
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email firstname.lastname@example.org