Officer, IPQA

Amneal Pharmaceuticals LLC; India; On-site; INR 700,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India is seeking an IPQA professional to support in-process quality assurance within a pharmaceutical manufacturing environment, helping define activities, processes, and standards to meet quality requirements for materials, components, and products.

The role assists in building infrastructure and systems to ensure timely delivery of quality products in compliance with regulatory standards, and participates in auditing, monitoring, and addressing deviations.

Responsibilities

• Assist in defining and specifying quality activities, processes, and standards for in-process quality assurance in pharmaceutical manufacturing in accordance with cGMP requirements
• Support the maintenance of quality infrastructure and systems to ensure timely delivery of compliant pharmaceutical products
• Participate in auditing and monitoring in-process manufacturing activities and outputs against defined internal and regulatory standards
• Assist in maintaining efficient workflows, procedures, policies, and inspection programs within the IPQA function
• Support in-process quality monitoring activities and assist in managing quality-related interactions with vendors
• Contribute to reporting and troubleshooting manufacturing process deviations and defects in finished goods
• Assist in compiling APQR reports and maintaining quality documentation in compliance with 21 CFR Part 210 and 211
• Support change control and deviation management processes under the guidance of senior quality personnel
• Participate in complaint and recall assessment activities and contribute to corrective and preventive action implementation

Job description

Description:

This role supports the in-process quality assurance function within a pharmaceutical manufacturing environment, contributing to the definition and specification of activities, processes, and standards required to fulfill quality requirements for manufactured materials, components, and products. The incumbent assists in building and maintaining the infrastructure and systems necessary to ensure the timely delivery of quality products in compliance with applicable regulatory standards. The role participates in auditing, monitoring, and determining the quality of in-process manufacturing activities and outputs against defined internal and regulatory standards. It supports the maintenance of efficient and effective workflows, procedures, policies, and inspection programs within the IPQA framework. The position assists in managing in-process product quality activities and communicates with relevant stakeholders in resolving quality-related issues. It contributes to reporting and troubleshooting manufacturing process deviations and defects in finished goods. This role provides structured exposure to pharmaceutical in-process quality assurance practices and regulatory compliance requirements within the Indian pharmaceutical manufacturing context.

Essential Functions:

• Assist in defining and specifying quality activities, processes, and standards for in-process quality assurance in pharmaceutical manufacturing in accordance with cGMP requirements
• Support the maintenance of quality infrastructure and systems to ensure timely delivery of compliant pharmaceutical products
• Participate in auditing and monitoring in-process manufacturing activities and outputs against defined internal and regulatory standards
• Assist in maintaining efficient workflows, procedures, policies, and inspection programs within the IPQA function
• Support in-process quality monitoring activities and assist in managing quality-related interactions with vendors
• Contribute to reporting and troubleshooting manufacturing process deviations and defects in finished goods
• Assist in compiling APQR reports and maintaining quality documentation in compliance with 21 CFR Part 210 and 211
• Support change control and deviation management processes under the guidance of senior quality personnel
• Participate in complaint and recall assessment activities and contribute to corrective and preventive action implementation

Additional Responsibilities: