M.Sc/ B.Pharm / M.Pharm. To plan, prepare and review of high quality dossier with support and guidance, assuring technical concurrency and regulatory compliance, meeting agreed upon timeline.
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.
Audit exposure in USFDA/ EUGMP approved company. Exposure of Material Handling / Electronic Batch Record filling and review / Good Knowledge of SAP System & Their T Codes for PPPI / Machine Alarms handling / QMS / Deviation / Change Control / SOP / Daily Reports Preparation/ Manpower Handling.