This role supports the 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 manufacturing processes and outputs against defined internal and regulatory standards. It supports the maintenance of efficient and effective workflows, procedures, policies, and inspection programs within the quality assurance 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 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 manufactured materials, components, and products 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 manufacturing processes and outputs against defined internal and regulatory standards
- Assist in maintaining effective workflows, procedures, policies, and inspection programs within the quality assurance 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