Junior Officer Manufacturing Process Operations

Amneal Pharmaceuticals LLC; Anakapalli; On-site; INR 250,000 - 420,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks an API Manufacturing Operator to support API production activities in a regulated facility. You will operate reactors, perform batch steps, and document results to ensure traceability and audit readiness.

The role emphasizes GMP compliance, safety, and quality, with involvement in process improvements and yield enhancement within Indian operations.

Qualifications

• Bachelor's degree (BA/BS) or B.Sc. is required.
• Master's degree (MS/MA) is preferred.
• 1 year or more experience in API manufacturing or related role.

Responsibilities

• Execute API manufacturing activities (charging, reactions, filtration, drying, material transfers) as per batch manufacturing records.
• Ensure all tasks comply with regulatory requirements including FDA and EMA guidelines.
• Operate process equipment such as reactors, centrifuges, dryers, and filtration systems per SOPs.
• Handle raw materials, solvents, and intermediates per GMP and safety requirements.
• Record process parameters, observations, and activities accurately in batch documentation.
• Maintain adherence to cGMP, safety guidelines, and regulatory requirements during all operations.
• Perform equipment cleaning, line clearance, and basic maintenance per procedures.
• Maintain cleanliness 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.

Education

Bachelors Degree (BA/BS) B. Sc. - Required

Master Degree (MS/MA) M. Sc. - Preferred

Job description

Job Description:

Description:

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:

Qualifications

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required

• Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 1 year or more in 1 - 4 Years