Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation and all changes during the life cycle of clinical trials.
To support for commercial troubleshooting/remediation/Market complaints for Non-Oral manufacturing sites.
To support for timely investigation/execution and to resume commercial manufacturing and to meet market/ sales requirement.
Dissolution apparatus, GC, IR and AAS and Documentation related to QMS. To review respective GMP Documents of QC department such as analytical / worksheet of In Process and Finished Product.