Description:

This role supports execution of API manufacturing operations by performing
process activities and ensuring accurate documentation in a regulated production
setting. 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 secure 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

Ad

📌 Junior Officer, Manufacturing Process Operations Visakhapatnam
🏢 Amneal
📍 Visakhapatnam