Execute API manufacturing activities as per approved BMR, SOPs, process parameters, and production plans. Handle shift operations and act as Shift In-Charge whenever assigned. Monitor and operate DCS/SCADA systems and review process alarms and critical parameters.

Ensure accurate and timely completion of manufacturing records and compliance with Good Documentation Practices (GDP) and data-integrity requirements. Coordinate sampling of raw materials, intermediates, and in-process materials with IPQC/QC. Make production entries and maintain relevant records in SAP/ERP systems.

Monitor availability of raw materials, solvents, consumables, labels, logbooks, and other production requirements. Coordinate with QA, QC, Stores/Warehouse, Engineering & Maintenance, Utilities, EHS, and other support functions. Identify and promptly report process abnormalities, deviations, equipment failures, and safety incidents.

Stop or hold an operation when a significant safety, quality, or process abnormality is identified and escalate to the appropriate authority. Ensure equipment cleaning, line clearance, housekeeping, and area hygiene as per approved procedures. Support preventive maintenance activities and ensure equipment availability for production.

Prepare, review, and maintain SOPs, BMRs, protocols, checklists, logbooks, and other production documents. Support qualification and validation activities, including equipment qualification, process validation, and cleaning validation where applicable. Participate in deviation investigations, CAPA, change controls, incident investigations, and other QMS activities.

Ensure compliance with cGMP, EHS, regulatory, and company requirements. Train operators and junior personnel on manufacturing procedures, GMP, safety,



and operational practices. Allocate work to operators and ensure effective manpower utilization during shifts.

Support process optimization, yield improvement, productivity improvement, and reduction of waste and downtime. Participate in internal, customer, and regulatory audits and ensure timely closure of observations. Maintain effective communication and shift handover to ensure continuity of operations.

Technical Competencies

Robust knowledge of API manufacturing processes such as reaction, distillation, crystallization, filtration, drying, and solvent handling. Knowledge of cGMP, GDP, data integrity, SOP, BMR/BPR, and QMS requirements. Working knowledge of DCS/SCADA systems.

Knowledge of SAP/ERP production transactions. Understanding of process safety, chemical handling, PPE, emergency procedures, and plant safety. Ability to understand process flow diagrams, equipment operations, and process parameters.

Knowledge of deviation, CAPA, change control, validation, and investigation processes.

Educational

Qualification B.Sc./M.Sc. in Chemistry, Industrial Chemistry, Pharmaceutical Chemistry, or related discipline; or B.E./B.Tech. in Chemical Engineering or equivalent qualification.

Experience Typically 3–8 years of relevant experience in API/pharmaceutical manufacturing, depending on the organization's grade and complexity of operations.

Key Performance

Indicators (KPIs) Production plan achievement Batch yield and productivity Right-first-time (RFT) / batch documentation compliance GMP and data-integrity compliance Deviation and CAPA closure Safety performance Equipment utilization and downtime Reduction of process losses and waste Training completion and operator competency Audit/inspection readiness

📌 Senior Executive (Mumbai)
🏢 Cadila Pharmaceuticals
📍 Mumbai