Visionary in life sciences; enterprise systems development; Innovative solutions to solve business problems & improve Business Performance. Center of Excellence integrate strategy, design, develop, train, implement & audit systems to achieve desired goals.
Expertise in the areas of manufacturing solutions, quality management, supply chain management, 21 CFR Part 11 and validation and system audit. Deep experience in design, development & implementation of supply chain management from IT strategy to Audit
Focus on Pharmaceutical, Regulatory & Process Vertical RESPA Product (An end to end business solution) support cGMP documentation requirements & USFDA 21CFR Part 11
CENTER OF EXCELLENCE FOR LIFE SCIENCE SYSTEMS
Specialities: System Strategy to Audit, World Class Manufacturing, e-Business solutions
Training Courses:
Experienced Technology Advisor & Solutions Architect who brings in broad technology expertise, management, and leadership skills with focus on technical excellence. Extensive experience in IT industry in various capacities like Technical Leadership, Business Development, Pre-Sales, IT Operations, Product Development, Project Management, Application Consulting and Business Consulting.
Experienced in building software and end-to-end products on Cloud Computing (AWS), Web, and Desktop. Having designed and delivered major ERP implementations, rollouts across India & Middle East regions. With the advent of Industry 4.0, consulting businesses in their quest for digital transformation and change the way they operate.
SKILLS :
CERTIFICATIONS :
Pharma Domain subject matter expert.
Pharma industry experience of three and half decades, with various fields in Pharma MNCs
– Manufacturing all dosage forms,
– Contract manufacturing: Facility design, Governance & Documentation
– Audits: Vendor audits, GMP Audits, HSE audits:
– Health safety Environment,
– Indirect Purchase
Pharma Graduate with post graduate Management qualification, both from Mumbai University.
Having a techno-commercial ability and analytical approach.
MS in Materials Science & Packaging Engineering and BS in Pharmacy with over 28 years of professional experience in pharmaceuticals, medical devices and consumer products
20 years packaging validation, PAI Readiness and Technology Transfer experience of Oral Solid Dosages, Injectibles, Liquids, Ointments and Creams of pharmaceuticals and medical devices in USA, Europe and Asia.
Global Subject Matter Expert (SME) responsible for the coordination and approval of all packaging validation functions of existing and new Technology Transfer products for FDA and Non-FDA regulated Global Finishing Sites at Schering-Plough Corporation in USA, Europe and Asia to include PAI Readiness and Validation
Experienced Advisor with a demonstrated history of working in the financial services industry. Skilled in Business Planning, Management, Mergers & Acquisitions (M&A), Start-ups, and Corporate Finance. Strong professional graduated from University of Mumbai and a Member of The Institute of Chartered Accountants of India.
Currently Management Consultant to SMEs in areas of Business Planning Organization Rightsizing, Customer relationships, and Operations management. Prior to that over 37 years experience in Business Operations, Sales and Marketing, Profit Centre management in roles starting from branch level to national level. In depth experience in spectrum of management functions.