Sunil Amin

About Sunil Amin

A pharmaceutical professional with 15 years of experience in clinical operations, packaging development, research and development, F&D, PPIC, production and external manufacturing in the fields of OSD, injectables, ointment, dermatology (creams, ointments, powder, lotions), oncology (OSD, parenteral), respiratory (MDI, aerosols, nasal sprays), and hormones (soft gelatin, cream, ointment). Develop packaging for CRO, OSD, respiratory, ointment, onco, and hormone products. During production and packing operations, work as a SAP coordinator, internal auditor, qualified trainer, managing QMS, vendor qualification, and troubleshooting. Continue to be in compliance by keeping up with laws and industry regulations. Managing the 150 operators/FTE and 40 TA team. Authorized technical person with the Indian Food and Drug Authority of INDIA (FDA).[PRODUCT DEVELOPMENT WITH MANUFACTURING OPERATION SPECIALIST IN BOTH PRODUCTION AND PACKAGING (OSD, PARENTERAL, CYTO, RESPIRATORY, HORMONES, SOFT CAPSULES, OINTMENT, CREAM, TOPICAL), MANAGING TRACKWISE IN QMS, CFT MEMBER IN CSV, MES, SAP, GAMP. ITM, ONLINE BMR IN GPMS.Machine qualification, validation, batch planning and execution, team training, and proficiency with computers (GraPHICS, GPM, HNG, SAP, ITM, MEDLIN, C++, data analysis, etc.) RISK ASSESSMENT, CHANGE CONTROL, INVESTIGATION, QMS HANDLING, SOP PREPARATION, AUDIT TRIAL REVIEW OF BATCHES, BMR REVIEW, DATA ANALYST OF MANUFACTURING]

Experience

1. Research and Development

   Glenmark Pharmaceuticals

   Aug 2024 — Present

   Clinical Research, R&D Packaging Development, NDA, ANDA, RLD Comparision study, RS comparison study.Handling SAP ( PP, MM,PM,SD,QM modules).Packaging Development for OSD, MDI, DPI,Nasal, Nebulising, Liquid,Semi solid & cosmetic dosage forms.Perform trials & Selection of Suitable PrimaryPackaging Materials.Testing and evaluation of packaging materials.Responsible for technical support for thedevelopment, Handling regulatory deficiency,procurement and troubleshooting of Packagingmaterials and components to support Site.Exposure DHF documents such as TAR, DDP, DI,DO, RMSR, UFMEA, DFMEA, URS, PRS, DVTPDVSR etc for US FDA, Notified body of Europeand Health Canada.Evaluate innovator packaging characterisationand prepare comparative container closuresystem data and prepare Report.Regulatory filing of USFDA, MHRA, TGA, FDA & ANVISA.Support technical documents for timelyof labels/Cartons.Approval of Artwork, shade card and text matterDevelop new source/s for new packagingmaterials.Prepare Documents like SPCs, STPs,MPC,Technical Protocols, Trade dress, Thresholdreport, PM & RM BOM, Packaging development report, Master Formulation Card review, Master packing Card preparation and review, TAR preparation.Clinical Trial Packaging Development. Assess In-house/ Outsource ManufacturingArtwork design for labels & Kits.Risk Management, Qualification, Handling QMS.Audit Compliance. Internal Audits. Vendor Audit.Domestic market, ROW, US, Russia and Brazil market.PDR and NPDR review of product.Review of stability study Protocols, accelerated stability testing, Real time stability testing, Excipient stability testing, Impurities studies, Assay, Dissolution test, DT test, Nitrosamine impurities study, in vivo and vitro study of product, validation, Assay of product.Participating in Cross-functional department meetings, quarterly management meeting, project meetings, Commercial Plant meeting and R&D meetings.Implementation of Kaizens.Process improvement.

Education

• Parul University, Vadodara

  Master of Business Administration - MBA, Business Administration, Management and Operations

• Gujarat University

  D.pharm

  2005 — 2006

• Gujarat University

  Bachelor of Pharmacy - BPharm, Pharmacy

Skills

• Quality Assurance
• Anda
• Biotechnology
• Generic Programming
• Standard Operating Procedure (Sop)
• Regulatory Affairs
• Project Planning
• Human Resources
• Validation
• Warehousing
• Capa
• Pharmaceutical Industry
• Sop
• Fda
• Pharmaceutics
• Technology Transfer
• Regulatory Requirements
• Pharmacovigilance
• Gmp
• Formulation
• Glp
• Cleaning Validation
• Corrective and Preventive Action (Capa)