Senior Executive

Plan and execute daily API manufacturing activities according to the approved production plan.
Supervise manufacturing operations such as raw-material charging, reaction, heating/cooling, extraction, distillation, crystallization, filtration, centrifugation, drying, milling, and packing, as applicable to the process.
Ensure manufacturing activities are performed according to approved BMR/BPR, SOPs, process parameters, and safety procedures.
Monitor critical process parameters and ensure operation within validated/approved ranges.
Ensure optimum utilization of manpower, equipment, raw materials, solvents, and utilities.
Monitor batch progress, cycle time, yield, and productivity and take appropriate action for deviations from planned targets.
Ensure timely completion and handover of batches to subsequent processing stages.
GMP & Documentation
Ensure strict compliance with cGMP, SOPs, BMR/BPR, GDP, and data-integrity requirements.
Review production documentation and ensure entries are complete, accurate, contemporaneous, and traceable.
Ensure proper line clearance, area clearance, equipment status identification, and equipment cleaning before and after manufacturing.
Identify and report process deviations, incidents, abnormal observations, and equipment-related issues.
Participate in investigations related to deviations, CAPA, change controls, OOS/OOT, process failures, and yield variations.
Support preparation and implementation of CAPA and other corrective/preventive actions.
Participate in regulatory, customer, and internal audits and provide required production-related information and records.
Team Management
Supervise and guide Production Officers, Executives, and Operators during manufacturing operations.
Allocate manpower according to production requirements and ensure effective utilization of resources.
Conduct on-job training on manufacturing processes, SOPs, GMP, safety, and documentation practices.
Monitor team performance and ensure adherence to production and safety procedures.
Promote a strong GMP, quality, and safety culture within the production area.
Equipment & Process
Ensure proper operation and cleaning of manufacturing equipment.
Coordinate with Engineering for equipment breakdowns, preventive maintenance, calibration, and troubleshooting.
Assist in equipment qualification and process validation activities.
Support process optimization, scale-up, technology transfer, and continuous improvement initiatives.
Identify opportunities to improve yield, cycle time, solvent recovery, energy consumption, and overall process efficiency.
Cross-Functional Coordination
Coordinate with QA, QC, Engineering, Warehouse, EHS, R&D/Process Development, and Planning to ensure smooth batch execution.
Coordinate with QC for sampling, testing, and release of intermediates and finished APIs.
Coordinate with QA for batch documentation, line clearance, deviations, and batch release requirements.
Coordinate with Warehouse for timely availability of approved raw materials, solvents, and packaging materials.
Work closely with EHS to ensure safe handling of chemicals, solvents, gases, and hazardous processes.
Educational Qualification
M.Sc. in Chemistry / Organic Chemistry
B.Sc. in Chemistry
B.Pharm / M.Pharm or Chemical Engineering qualification may be considered depending on the organization's requirements.
Experience
Typically 4–7 years of relevant experience in API Production.
Experience in chemical synthesis, API manufacturing, and GMP-compliant pharmaceutical production preferred.
Hands-on experience in batch manufacturing and handling production teams is desirable.
Technical Competencies
API chemical synthesis and manufacturing
Reaction chemistry and process parameter control
Crystallization and precipitation
Filtration / centrifugation
Drying and milling
Solvent handling and recovery
Batch manufacturing and documentation
cGMP / GDP / Data Integrity
Deviation, CAPA, and Change Control
Process validation
Equipment troubleshooting
EHS and chemical safety
Production planning and execution
Key Performance Indicators (KPIs)
Batch execution as per production schedule
Batch yield and productivity
Cycle-time adherence
Right-first-time batch documentation
Reduction in process deviations
GMP compliance
Equipment utilization
Manpower productivity
Solvent/raw-material efficiency
Safety performance
Timely implementation of CAPA and improvement actions
Core Competencies
Leadership and team management
Decision-making
Problem-solving
Process understanding
Analytical thinking
Cross-functional coordination