Quality Analyst

Job Description

Company: TAPI
Location: Gajraula, Uttar Pradesh, India
Job Type: Full-Time
Experience: 7 – 10 years in pharma / quality roles
Education: B.Sc. / M.Sc. in Chemistry or B.Tech / BE in Chemical Engineering
Expected Salary: ₹6,00,000 – ₹10,00,000 per year
Job Category: Information Technology, Engineering, Healthcare
Website: Website
Contact: Contact us

About the Company:
TAPI is a global leader in active pharmaceutical ingredients (APIs), supplying to over 80% of the top 50 global pharma firms.
With over 80 years of legacy and more than 350 products, TAPI also offers CDMO services across its 13 world-class facilities.
The company values innovation, excellence, and a mission to transform global health.

About the Role:
We are looking for a meticulous Quality Analyst to join our Quality Assurance team at the Gajraula site.
You will review manufacturing and documentation processes, ensure GMP compliance, validate corrective actions, and support regulatory interfaces.
Your work will be central to maintaining product quality and regulatory integrity across the product lifecycle.

Key Responsibilities:
📌 Review batch records, change controls, CAPA, deviations, validations, and other documents before batch disposition
📌 Monitor compliance to manufacturing and packaging protocols, address errors and deviations
📌 Lead investigations, ensure timely closure of events with corrective and preventive actions
📌 Evaluate effectiveness of CAPA actions and audit process and procedural changes
📌 Coordinate with internal and external stakeholders on quality issues, movement of materials, and compliance
📌 Oversee technical transfer, R&D support, and validation protocols
📌 Review and approve cleaning validations, continuous process verifications, and GMP documentation
📌 Participate in internal audits, monitor quality metrics, and maintain periodic reports

Requirements:
🎯 7 – 10 years of experience in API / pharmaceutical quality assurance
🎯 Strong understanding of GMP, validation, CAPA, deviation management
🎯 Experience with documentation review (batch records, protocols, COA)
🎯 Analytical mindset and problem-solving ability
🎯 Good communication skills and stakeholder collaboration
🎯 Ability to work on shop floor and interface with operations teams

Why Join TAPI?
✅ Be part of a globally respected API company with deep domain impact
✅ Work in a mission-driven environment that values excellence and integrity
✅ Engage in high-responsibility tasks with visibility and growth potential
✅ Opportunity to contribute to R&D, regulatory, and quality operations across multiple domains