Company Description

At TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we’re shaping the future of health worldwide.

Our strength lies in our people—a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives.

Job Description

Purpose of the Job

To ensure compliance of Quality Systems with GMP, regulatory, and corporate requirements through effective management of validation, change control, documentation, qualification, training, quality metrics, audits, and continuous improvement activities. The role provides quality oversight and support to manufacturing, laboratory,



engineering, and regulatory functions to maintain product quality, data integrity, and regulatory compliance in an API manufacturing setting.

Key Responsibilities

Data Management & Analysis: Collect, compile, analyze, and review data related to manufacturing, testing, sourcing, deviations, stability studies, and change controls to support and maintain the validated status of products.
Batch Documentation Control: Manage and ensure the controlled issuance of Batch Manufacturing Records (BMRs) and related documentation, including assignment of batch numbers and issuance to operations for execution.
Change Control Management: Oversee the Change Control process, including initiation, impact assessment, review, approval, implementation, and closure of changes related to GMP systems and operations.
Validation & Qualification Oversight: Review and approve validation protocols, reports, and qualific

📌 Quality Senior Specialist (Burhanpur)
🏢 Tapi
📍 Burhanpur