Trainee Executive, QMS

Amneal India; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal India is seeking a Quality professional to define and specify quality activities, processes, and standards for the Quality Management System in compliance with regulatory requirements.

The role builds and maintains quality infrastructure and systems to ensure timely delivery of compliant pharmaceutical products, conducts audits, and coordinates with customers and vendors to resolve quality-related issues.

Qualifications

• Experience implementing and maintaining Quality Management System in pharmaceutical manufacturing.
• Understanding of GMP guidelines and regulatory requirements.

Responsibilities

• Define and specify quality activities, processes, and standards for the Quality Management System 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 processes and outputs against internal and regulatory standards including GMP guidelines
• Ensure efficient workflow, procedures, policies, and inspection programs are implemented and maintained across operations
• Manage in-process product quality in coordination with vendors and contract manufacturers to meet defined quality specifications
• Communicate with customers and vendors to investigate and resolve quality-related issues in a timely manner
• Report and troubleshoot manufacturing process deviations and defects identified in finished goods
• Support the development and maintenance of Quality Management System documentation and frameworks aligned with regulatory requirements
• Identify and implement process improvements to reduce costs, defects, errors, and rework in operations

Job description

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 development, implementation, and maintenance of the Quality Management System to ensure organizational compliance with regulatory and internal standards. The role ensures efficient and effective workflows, procedures, policies, and inspection programs are in place and adhered to across 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 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 the Quality Management System 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 processes and outputs against internal and regulatory standards including 21 CFR Part 210 & 211 and GMP guidelines
• Ensure efficient workflow, procedures, policies, and inspection programs are implemented and maintained across operations
• Manage in-process product quality in coordination with vendors and contract manufacturers to meet defined quality specifications
• Communicate with customers and vendors to investigate and resolve quality-related issues in a timely manner
• Report and troubleshoot manufacturing process deviations and defects identified in finished goods
• Support the development and maintenance of Quality Management System documentation and frameworks aligned with regulatory requirements
• Identify and implement process improvements to reduce costs, defects, errors, and rework in operations