Job Description:

Principal Tasks & Responsibilities
Production Operations
 Execute API manufacturing activities as per approved Batch Manufacturing Records (BMR) and Standard Operating
Procedures (SOPs).
 Operate and monitor reactors, centrifuges, dryers, filters, and other process equipment safely and efficiently.
 Verify the availability of raw materials, intermediates, utilities, and equipment before batch execution.
 Perform line clearance before the start and after completion of each batch.
 Monitor critical process parameters and ensure compliance with approved process instructions.
 Report process deviations, abnormalities, and equipment issues promptly to the supervisor.
Documentation & Compliance
 Maintain accurate and timely documentation in Batch Manufacturing Records (BMRs), equipment logbooks, and
SAP/ERP systems.
 Ensure compliance with cGMP, GDP, SOPs, and regulatory requirements during all manufacturing activities.
 Support data integrity and documentation practices in line with regulatory expectations.

Quality & Validation





 Coordinate with QA and QC for in-process sampling, testing, batch release, and deviation investigations.
 Support equipment qualification, process validation, cleaning validation, and technology transfer activities.
 Participate in investigations, change controls, deviation management, and CAPA implementation.
Equipment & Maintenance
 Ensure proper cleaning, sanitization, and maintenance of equipment and production areas as per SOPs.
 Coordinate with the Engineering department for preventive maintenance and equipment breakdown resolution.
 Ensure equipment is maintained in a qualified and operational condition.
Safety, Health & Environment (EHS)
 Follow all EHS policies and secure operating procedures during manufacturing activities.
 Ensure proper handling, storage, and disposal of hazardous chemicals and production waste.
 Participate in safety trainings, risk assessments, and emergency response activities.
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📌 Assistant General Manager (Ankleshwar)
🏢 DigiCAD
📍 Ankleshwar