Junior Officer, Manufacturing Process Operations
About this role
This role supports execution of API manufacturing operations by performing process activities and ensuring accurate documentation in a regulated production environment. The role involves operating process equipment and executing batch manufacturing steps such as charging, reaction monitoring, filtration, drying, and material transfers in accordance with batch manufacturing records and standard operating procedures. The incumbent handles raw materials and intermediates while ensuring adherence to GMP, safety, and quality standards. It maintains accurate and timely documentation of all manufacturing activities to ensure traceability and audit readiness. The role contributes to consistent batch execution, regulatory compliance, and operational efficiency while supporting continuous improvement initiatives in API manufacturing processes.
Essential Functions:
- Execute API manufacturing activities (charging, reactions, filtration, drying, material transfers) as per batch manufacturing records
- Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines
- Operate process equipment such as reactors, centrifuges, dryers, and filtration systems in compliance with SOPs
- Handle raw materials, solvents, and intermediates in line with GMP and safety requirements
- Record process parameters, observations, and activities accurately in batch documentation
- Ensure adherence to cGMP, safety guidelines, and regulatory requirements during all operations
- Perform equipment cleaning, line clearance, and basic maintenance as per defined procedures
- Maintain cleanliness, housekeeping, and safe working conditions in manufacturing areas
- Identify and report process deviations, abnormalities, and safety concerns promptly
- Support in-process checks and sampling to ensure product quality and consistency
- Participate in process improvement, yield enhancement, and operational efficiency initiatives
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.
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