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Preparation, compilation & review of regulatory dossier, submission & reply queries, documentation & control related USFDA/TGA/Who guidlines & compliance, documents for drugs authority, review of art work, coordination with QA/QC/R&D, External Audit
Planning, Organiging & controlling overall plant functions, work closely to production, QC/QA, raw material store, Admn. maintenance & dispatch deptt.. Planning for man & machine utilization