Description:

This role is responsible for defining and specifying the activities, processes,
and standards required to fulfill quality requirements for manufactured
materials, components, and products within a global pharmaceutical environment.
The position builds and maintains the infrastructure and systems necessary to
consistently ensure the timely delivery of quality-compliant products. It
supports the auditing, monitoring, and evaluation of manufacturing processes and
outputs against defined internal and regulatory standards. The role ensures
efficient and effective workflows, procedures, policies, and inspection programs
are in place and adhered to across manufacturing operations. It manages
in-process product quality in coordination with vendors and contract
manufacturers. The position facilitates communication with customers and vendors
to resolve quality-related issues in a timely and compliant manner. It reports
and troubleshoots manufacturing process deviations and defects identified in
finished goods. The role contributes to continuous improvement initiatives aimed




at reducing defects, errors, and rework across manufacturing operations. It also
supports the identification and development of outsourcing vendors and suppliers
according to organizational quality standards.

Essential Functions:
* Define and specify quality activities, processes, and standards for
manufactured materials, components, and products in compliance with
regulatory requirements

* Build and maintain quality infrastructure and systems to ensure timely
delivery of compliant pharmaceutical products

* Conduct audits and monitoring of manufacturing processes and outputs against
internal and regulatory standards including 21 CFR Part 210 & 211 and GMP
guidelines

* Ensure productive workflow, procedures, policies, and inspection programs are
implemented and maintained across manufacturing operations

* Manage in-process product quality in coordination with vendors and contract
manufactu

📌 Senior Executive, Quality Assurance (India)
🏢 Amneal India
📍 India