Job Description:

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 adher

📌 Senior Executive Mumbai
🏢 DigiCAD
📍 Mumbai