Officer, IPQA
About this role
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:
Company at a glance
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Tired of cold applications?
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Know someone who'd be great for this?