Assistant General Manager

Role Objective / Major Purpose of the Job
The Production API Officer is responsible for executing Active Pharmaceutical Ingredient (API) manufacturing activities
in compliance with cGMP, SOPs, safety standards, and regulatory requirements. The role ensures timely production,
optimum utilization of resources, maintenance of product quality, and adherence to production schedules while
supporting continuous improvement initiatives.

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 safe 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.
Continuous Improvement
Minimize material loss and process downtime to improve production efficiency.
Participate in productivity improvement, cost reduction, and Lean/Continuous Improvement initiatives.
Support internal audits, customer audits, and regulatory inspections by ensuring audit readiness.

Key Skills & Competencies

Functional / Technical:
Knowledge of API manufacturing processes
cGMP, GDP, and regulatory compliance
Batch Manufacturing Record (BMR) documentation
Operation of reactors, centrifuges, dryers, filters, and other process equipment
Chemical process and reaction knowledge
Process troubleshooting and root cause analysis
Process validation and equipment qualification
SAP/ERP knowledge
EHS practices and hazardous chemical handling
MS Office (Excel, Word, PowerPoint)

Behavioural:
Teamwork & Collaboration
Effective Communication
Result Orientation
Attention to Detail
Problem Solving
Accountability & Ownership
Time Management