For US Market :-Drug Dossier Authoring, Reviewing & Submission of ANDA (US) Product life cycle management (LCM) activitiesAssessment of post approval changes eCTD publishing Thorough knowledge ...view more
Issuance and retrieval of Batch Manufacturing RecordsIssue copy of Master Batch Production Instructions to production for batch manufacture & review critical control parameters before release of the b...view more
Compliances & Audit - Maintain the area with zero non-compliance & zero critical incidents, Monitoring the systems as per the instructions of the SOPs, To review and comply the observation of internal...view more