About this role
Experience
3–7 years of relevant experience in API production/manufacturing, preferably in a GMP-regulated pharmaceutical facility.
Job Overview
Responsible for executing and monitoring API manufacturing operations as per approved batch manufacturing procedures, SOPs, GMP requirements, safety standards, and production plans. The position will coordinate with QA, QC, Engineering, Warehouse, and EHS to ensure safe, efficient, and compliant batch manufacturing.
Key Responsibilities
Execute API manufacturing activities as per approved BMR/BPR, SOPs, and manufacturing instructions.
Monitor and control manufacturing processes and critical process parameters.
Handle operations such as:
Reactor charging and reaction
Heating and cooling
pH adjustment
Extraction and separation
Filtration and centrifugation
Washing
Drying
Milling / sieving
Blending
Packing and material transfer
Ensure production activities are completed according to the approved production schedule.
Operate and monitor manufacturing equipment safely and efficiently.
Verify raw materials, intermediates, solvents, and other materials before use.
Ensure proper equipment cleaning, line clearance, and area readiness before batch operations.
Complete batch documentation accurately and in accordance with Good Documentation Practices (GDP).
Monitor process parameters and immediately report abnormalities or deviations.
Initiate and support deviation investigations, CAPA, change control, and root-cause analysis.
Coordinate with QA/QC for sampling, in-process testing, and batch release activities.
Coordinate with Engineering/Maintenance for equipment breakdowns and maintenance requirements.
Ensure compliance with cGMP, SOPs, EHS requirements, and data-integrity principles.
Maintain proper housekeeping and 5S in production areas.
Ensure safe handling of chemicals, solvents, intermediates, and APIs.
Conduct shift handovers and communicate batch status, issues, and pending activities.
Train and guide operators on manufacturing procedures, GMP, safety, and equipment operation.
Support process validation, cleaning validation, technology transfer, scale-up, and trial batches.
Participate in internal, customer, and regulatory audits and provide required documentation/support.
Monitor production losses, yields, cycle times, and process efficiency.
Technical Knowledge
Good understanding of API manufacturing processes.
Knowledge of chemical reactions and process parameters.
Understanding of reactors, centrifuges, filters, dryers, mills, blenders, pumps, and vacuum systems.
Knowledge of cGMP, GDP, ALCOA+ data integrity principles, and pharmaceutical documentation.
Understanding of deviation, CAPA, change control, and risk-management processes.
Knowledge of process safety and hazardous chemical/solvent handling.
Qualification
B.E./B.Tech – Chemical Engineering
or
M.Sc. Chemistry / B.Pharm / M.Pharm, depending on the organization's requirements.
Key Competencies
API manufacturing knowledge
Batch execution
GMP compliance
Process monitoring
Documentation
Problem-solving
Team coordination
Safety awareness
Cross-functional communication
Production planning and execution
Key Performance Indicators (KPIs)
Production plan achievement
Batch cycle-time adherence
Batch yield and productivity
Right-First-Time (RFT) performance
Reduction in production deviations
GMP/documentation compliance
Equipment utilization
Reduction in process losses