AMV Manager

Role & responsibilities

To manage the activities of analytical method validation, analytical method verification, analytical method transfer, cleaning method, photo stability studies, process optimization and equivalency Studies.

Person should have good knowledge of Dissolution, HPLC, GC and other analytical Instruments.

To review or approve analytical raw data, protocols, worksheets and reports related to analytical method validation, analytical method verification, analytical method transfer, cleaning method, photo stability study, process optimization and equivalency Study.

To handle QMS as per site-SOP (Lab Incidence, Deviations, System suitability criteria, Change control through EDMS and "Trackwise QMS".

To handle Laboratory investigations during method validation and verification and Analytical method

Transfers activities. To do Investigation of root cause and implementation of CAPA.

To prepare monthly project schedule based on EB, SU batches schedule, instrument and processing methods preparation for HPLC analysis in empower software.

To Handle and manage various inspections and audits by the external and internal teams / agencies viz. USFDA, MHRA, TGA, Site-QA and CQA.