Manager

To lead and manage end-to-end API manufacturing operations, ensuring safe, efficient, compliant and cost-effective production. The role is responsible for managing multiple production blocks, achieving production targets, optimizing manpower and resources, ensuring adherence to cGMP, regulatory requirements and EHS standards, and driving operational excellence across the manufacturing facility.
2. Key Roles & Responsibilities
A. Production Operations & Execution
- Lead day-to-day API manufacturing operations across multiple production blocks.
- Ensure execution of production plans as per approved monthly and weekly schedules.
- Monitor batch execution, cycle time, yield, productivity and equipment utilization.
- Ensure timely completion of manufacturing activities as per BMR and approved SOPs.
- Monitor critical manufacturing operations such as reactions, distillation, filtration, centrifugation, drying, milling and packing.
- Ensure proper utilization of reactors, centrifuges, ANFDs, dryers, filters and other process equipment.
- Review production reports, batch records, shift reports and manufacturing performance.
- Coordinate with Planning, QA, QC, Engineering and Warehouse for uninterrupted production.
B. GMP & Regulatory Compliance
- Ensure strict adherence to cGMP, Schedule M, SOPs and applicable regulatory requirements.
- Ensure accurate execution and documentation of Batch Manufacturing Records (BMR).
- Maintain data integrity and ensure ALCOA+ compliance.
- Ensure compliance with process validation, cleaning validation and equipment qualification requirements.
- Coordinate with QA during internal audits, customer audits and regulatory inspections.
- Ensure timely closure of deviations, incidents, CAPAs and change controls.
- Drive audit readiness and maintain a high level of GMP compliance across production blocks.
C. Process Optimization & Operational Excellence
- Identify opportunities to improve batch cycle time, process efficiency and manufacturing productivity.
- Drive initiatives to improve yield and reduce process losses.
- Optimize solvent consumption, energy utilization and raw material consumption.
- Implement initiatives for cost reduction and waste minimization.
- Drive continuous improvement through Lean Manufacturing, Kaizen and 5S.
- Analyze recurring process deviations and implement sustainable corrective actions.
- Work towards improving overall equipment effectiveness (OEE).
D. Manpower & Team Management
- Lead and manage Production Managers, Assistant Managers, Executives, Officers, Supervisors and contractual manpower.
- Ensure optimum manpower deployment across production blocks and shifts.
- Develop shift in-charges and production team members through structured capability-building initiatives.
- Establish clear KRAs, KPIs and performance expectations for the production team.
- Conduct periodic performance reviews and provide constructive feedback.
- Build a performance-driven culture with accountability, discipline and ownership.
- Ensure adequate manpower availability for critical manufacturing operations.
E. EHS & Process Safety
- Ensure strict compliance with EHS policies and process safety requirements.
- Monitor safe handling of hazardous chemicals, solvents, acids, alkalis and toxic materials.
- Ensure adherence to PPE requirements, permit-to-work systems and LOTO procedures.
- Ensure implementation of process safety controls, including MOC and risk assessments.
- Coordinate with EHS for HAZOP, safety audits and incident investigations.
- Drive near-miss reporting and safety improvement initiatives.
- Ensure emergency preparedness and safe operating practices across production areas.
F. Equipment & Engineering Coordination
- Coordinate with Engineering and Maintenance for preventive and breakdown maintenance.
- Ensure availability and reliability of critical production equipment.
- Monitor equipment breakdowns and their impact on production schedules.
- Ensure proper equipment cleaning, line clearance and equipment logbook maintenance.
- Participate in equipment commissioning, qualification and process improvement projects.
- Ensure timely resolution of recurring equipment-related production challenges.