Rajesh Sirwani
Head Of Research And Development
About
Specialties: Research and Development (Formulation development--Brazil, Mexico, US and ROW ) (Formulation development to technology transfer. )
India
Mumbai
Pharmaceuticals
Generic Programming, Business Development, Pharmaceutics, Regulatory Affairs, ANDA, Technology Transfer, Validation, Formulation, Drug Delivery, GMP, Pharmaceutical Industry, Regulatory Submissions, Sop, Drug Discovery, Dissolution, Pharmaceutical Research, Cleaning Validation, HPLC, GLP, Regulatory Requirements
Experience

Head Of Research And Development
Shalina Labs Pvt. Ltd.
Navi Mumbai, Maharashtra, India

General Manager
Zydus Cadila -COE Head Brazil

Deputy General Manager
Alkem labs Ltd

Asst. General Manager
Elder Pharmaceutical Ltd India
• Formulation development, validation and preparation of master documents (master formula records and specifications of raw material, packing materials and finished products etc.) • Preparation of product dossier for different countries for registration of product. • Actively involved in ISO 9000 documentation and conducting Internal audit of various other departments. • Audit preparation and preparation of site master file etc. • Deputation by company to monitor, standardizes, and validates tablet, capsule and liquid oral at different locations. • Troubleshooting / yield improvement, cost reduction. • Technology Transfer for production and optimization. • Literature and patent Search. • Preparation of validation protocol and validation batches. • Worked on various OTC products such as : Lozenges (Workz of Piramal healthcare) , soft chews and creams • Formulation and process development of following dosage form : 1. Tablets : Tablets with aqueous, non-aqueous coating and sugar coating, chewable tablets, Dispersible tablets ,modified release tablets,Bilayered tablets . 2. .Liquid orals : Suspensions, syrups and dry syrups. 3. Injectable and Ophthalmic preparations Novel Drug Delivery System like Floating Drug Delivery System (FDDS) , Oral Drug Delivery Systems For Extended Time ,Transdermal drug delivery systems, Controlled Release liquids

Sr. Group Leader
Nicholas Piramal India Ltd

PSR
Sun Pharmaceutical and Almet Ltd
Rajesh Sirwani's Contact Information
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