Shabaz Khan
Senior Validation Specialist @Serum Institute Of India Pvt. Ltd
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WORK HISTORY
Senior Validation Specialist @Serum Institute Of India Pvt. Ltd
Pune, IN
Key Responsibilities- Lead and manage all aspects of validation activities, including planning, execution, review, and approval of IQ, OQ, PQ protocols and reports- Develop and maintain a comprehensive validation master plan (VMP)- Provide strategic guidance on process validation, cleaning validation, HVAC, water systems, and computer system validation (CSV)- Ensure compliance with global regulatory requirements (USFDA, WHO, EMA, MHRA, etc.) and internal quality standards- Drive cross-functional coordination with QA, Engineering, Production, IT, and Regulatory Affairs to ensure validation alignment with project timelines- Support internal and external audits, and prepare validation documentation for regulatory inspections- Mentor and supervise a team of validation engineers, review their work for technical accuracy and compliance- Asses and implement industry best practices, data integrity principles, and emerging validation technologies.
EDUCATION
Savitribai Phule Pune University
Bachelor of Computer Applications - BCA
ABOUT SHABAZ KHAN
Starting out with a degree in Computer Applications, I quickly discovered that I wasn’t just fascinated by code—I was hooked on solving problems. My curiosity led me beyond software into the world of systems, processes and quality assurance, eventually landing me where innovation meets impact: validation engineering.Today, I’m proud to be part of the mission at Serum Institute of India, where I ensure that the processes behind vaccines and biologics are as precise, compliant and efficient as possible. Whether it\'s validating equipment or optimizing protocols, I thrive on making complex systems run smoothly—because when lives are at stake, there’s no room for guesswork.Tech-savvy, quality-driven and always up for a challenge—I’m on a mission to bridge the gap between code, compliance and care.
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