Jenulabedin Bhayji
Analytical Laboratory In-Charge | QA,CAPA & Compliance | Expert in GMP & GDP
- Role
- Assistant Manager at Abbott
- Location
- Bharuch, GJ, IN
- LinkedIn followers
- 500 followers
About Jenulabedin Bhayji
As a competent professional with over 11+ years of experience in Quality Control, I…
Experience
Assistant Manager
Feb 2023 — Present · Jhagadia, IN
Analytical Laboratory In-ChargeAs the overall in-charge of Analytical QA, I lead the QA function with a team of 22 members, ensuring the seamless release of raw materials, in-process, and finished products. My responsibilities include:• Leadership & Team Management: Leading a team of 22 members, ensuring 100% on-time releases as per MSP, and maintaining zero loss time accident incidents in labs.• Quality Assurance: Overseeing lab releases for raw materials, in-process, and finished products. Leading data integrity improvement plans and establishing short interval controls for labs.• Vendor & Stability Management: Managing 100% vendor and stability testing, ensuring compliance with GMP and GDP standards.• Budget Management: Managing budgets with 100% accuracy and achieving significant cost savings through quality initiatives.• Compliance & Improvement: Working closely with site and global teams for continuous compliance and improvements. Leading new product introductions, technology transfers, and regulatory submission support.• Training & Development: Supporting GMP and GDP training for personnel and monitoring training plans for compliance.• Audit & Governance: Conducting internal audits, gap assessments, and monitoring the effectiveness of the Quality Management System.• Operational Excellence: Driving excellence within the QA function, promoting a quality culture, and achieving significant cost savings through innovation and lean projects.Key Achievements:• Achieved over $50M in cost savings through quality initiatives.• Successfully driven innovation and lean ideology with Green Belt and Yellow Belt project completions.• Maintained a team retention rate of over 95% with zero loss time accidents.• Led the qualification of manufacturing and control activities at contract manufacturers and testing facilities.• Supported the preparation of Site CAPA based on regulatory audit findings.• Monitored key quality KPIs and ensured 100% metrics achievement.
Education
Parul institute of pharmacy
Master's degree
2013 — 2015
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