Method Validation protocols / Reports.
Review of spaces and STP / TDS/ Raw Material/ In-Process/ Intermediate. Analytical dossier of API / Intermediate / Stability / Standard qualification / Calibration report/ Analytical Report/ COA.
Ensuring Adequate GDP / GLP system in ADL.
Management of Deviations/ Incidences/ Investigations/ SOPs review.
Handling of Sophisticated Instruments like GC, HPLC, GC-HS, etc.
Development of Instrumental / chemical analysis method if required.
Provide analytical support to plant / PDL for the additional analysis & troubleshooting.
Recording and documentation as per GLP and related cGMP aspects.
Technical analytical interaction with other department and other location as required.
Any other duties assigned by the Management time to time.