Kundan Niphade
Manager @ Sandoz | People Management, CAPA, Compliance, Operational Excellence, Serialization
- Role
- Production Manager at Sandoz
- Location
- Navi Mumbai, IN
- LinkedIn followers
- 500 followers
About Kundan Niphade
As a manager at Sandoz, a global leader in generic and biosimilar medicines, I have over 15 years of experience in the pharmaceutical industry. I am skilled in People Management, Shop floor Handling, influence the Higher management, Delivering KPI - OTIF, PSP, RFT, Work safety,computer system validation, operational risk management, and regulatory compliance for various manufacturing and packaging operations. I conduct risk assessment, gap analysis, validation planning, testing, reporting, and audit readiness for the systems and processes that support the production and distribution of high-quality products. I am also responsible for people management, delivering packing KPI like OTIF, PSP, RFT etc, and contributing to process optimization, quality improvement, and cost reduction projects. I work with a diverse and cross-functional team of engineers, technicians, quality assurance, and regulatory affairs professionals, and I empower them to meet the highest standards of safety and efficacy. I am passionate about ensuring the reliability and integrity of the systems and processes that support the production and distribution of affordable and accessible medicines for millions of patients around the world.
Experience
Production Manager
Aug 2016 — Present · Mumbai, IN
Skills
- Pharmaceutical Manufacturing
- Cleaning Validation
- Regulatory Affairs
- Product Launch
- 21 Cfr Part 11
- Sop Development
- Pharmaceutical Packaging
- Cgmp Practices
- Dissolution
- Pharmaceutical Industry
- Formulation
- Anda
- Validation
- Capa
- Gmp
- Pharmaceutical Sales
- Deviations
- Sop
- Pharmaceutics
- Regulatory Requirements
- Ich-Gcp
- Change Control
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