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 & Workplace (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

📌 Assistant General Manager (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar