Arjune

Background

About Arjune

Pharma Manufacturing Professional with 23 + years of progressive management experience in ensuring Operational Goal is met.Skilled in overseeing Manufacturing Operation, heading activities aimed at ensuring efficient Business includes Operational Efficiency, Capacity Planning and Creation, Technology Transfer with statutory compliance including International Regulatory (e.g, US-FDA, UK-MHRA, EU, TGA-Australia, ANVISA- Brazil, WHO-Geneva) and Vendor (e.g, Merk,Teva, Perrigo and Serdia etc)for Solid Oral, Semi-Solid, and Liquid Dosage Form.Successfully handled responsibility for Solid Oral facility - Expansion plan, from installation to commercialization including qualification/validation & regulatory/vendor approvals at V-Ensure Pharma Technologies pvt ltd at Patalganga Navi Mumbai, RV lifescience pvt ltd at Aurangabad,Flamingo Pharmaceuticals ltd at Nanded,Micro Ltd at Goa, Cipla ltd at Goa,Indoco Remedies at Goa.Core Competencies:Production Operation: Oral Solid Dosage Form - Tablets, Pellet,Form (Immediate, Delayed, Modified, Dispersible, Effervescent, Sustained Release, Time Release,Hard Gelatin Capsules, Dry Syrup,Liquid.• Capacity Planning, Utilization, KAIZEN, project planning and commissioning.* High potent compound-hormones Manufacturing systems and containment.* Quality Risk Assessment & Management for Product/Process and Occupational Hygiene* Change Control and Deviation management* Regulatory and Statutory compliance (USDA, MHRA, EU, WHO Geneva, ANVISA and Emerging.