Deputy Manager

Role Objective / Major Purpose of the Job
The Deputy Manager – Production API is responsible for planning, managing, and monitoring API manufacturing
operations to ensure safe, efficient, and timely production in compliance with cGMP, regulatory requirements, and
company quality standards. The role focuses on achieving production targets, optimizing resources, ensuring regulatory
compliance, developing team capabilities, and driving 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:
echnical Competencies
 Strong knowledge of API Manufacturing Processes
 cGMP, GDP & Regulatory Compliance
 Process Scale-up & Technology Transfer
 Batch Manufacturing Documentation (BMR/BPR)
 Process Validation & Cleaning Validation
 Equipment Qualification
 Root Cause Analysis (RCA) & CAPA
 SAP / ERP Systems
 Production Planning & Resource Management
 EHS & Risk Assessment
 MS Office Applications
Behavioural:
 Leadership & Team Management
 Decision Making
 Planning & Organizing
 Problem Solving
 Communication & Interpersonal Skills
 Result Orientation
 Analytical Thinking
 Continuous Improvement Mindset
 Accountability
 People Development
 Accountability & Ownership
 Time Management