Description
Summary:- Provides project support with current Good Manufacturing Practices to clinical supply packaging operations.
- Provides guidance on procedures and training necessary to be in complete compliance with current GMPs.
- Risk Assessments of Potential Data Integrity Gaps
- Operational Computer Support Activities for QC
Additional Skills:
- High level of experience with LIMS is required.
- Need someone with extensive knowledge of computer systems integrations within the laboratory.
- Knowledge of Laboratory Information Management Systems (LIMS).
- Knowledge of the MHRA new guidance as it relates to data integrity.