Deputy General Manager

1\. Job Purpose

The Deputy General Manager – Production is responsible for managing and overseeing the overall pharmaceutical manufacturing operations to ensure efficient, timely, and compliant production of quality products. The role involves strategic planning, execution, monitoring, and continuous improvement of manufacturing activities to achieve organizational production targets while maintaining the highest standards of quality, safety, productivity, and regulatory compliance.

The incumbent will lead the production team, optimize manufacturing resources, improve operational efficiency, reduce manufacturing costs, and ensure adherence to current Good Manufacturing Practices (cGMP), applicable regulatory guidelines, and company policies. The position requires strong technical knowledge, leadership capabilities, decision-making skills, and the ability to coordinate effectively with cross-functional departments.

2\. Key Roles and Responsibilities

**A. Production Planning and Manufacturing Operations**

- Develop, plan, and execute production strategies in alignment with the approved monthly and annual production plans.
- Ensure achievement of production targets in terms of quantity, quality, cost, and timelines.
- Monitor daily manufacturing activities and ensure smooth execution of production operations across all assigned manufacturing areas.
- Ensure effective utilization of manpower, machinery, materials, and available manufacturing capacity.
- Review production schedules and coordinate with Production Planning and Control (PPC), Warehouse, Quality Assurance, Quality Control, and Engineering departments for uninterrupted manufacturing operations.
- Monitor batch manufacturing activities to ensure timely completion and adherence to approved Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs).
- Identify operational bottlenecks and implement appropriate corrective actions to improve manufacturing efficiency.
- Ensure proper shift management, manpower allocation, and effective coordination among production teams.
- Monitor production performance and take necessary actions to minimize downtime, process losses, and operational delays.

**B. GMP and Regulatory Compliance**

- Ensure complete adherence to current Good Manufacturing Practices (cGMP), applicable Schedule M requirements, WHO-GMP, and other relevant regulatory guidelines.
- Ensure that all manufacturing activities are performed strictly according to approved SOPs, BMRs, BPRs, specifications, and established quality systems.
- Maintain a high level of GMP compliance across all production areas.
- Ensure proper implementation of data integrity principles, including ALCOA+ requirements, in all manufacturing and documentation activities.
- Ensure production personnel follow approved procedures for line clearance, equipment cleaning, area cleaning, material dispensing, manufacturing, and packaging operations.
- Coordinate with Quality Assurance for timely closure of deviations, CAPA, change controls, and other quality-related investigations.
- Ensure production areas remain inspection-ready for regulatory inspections, customer audits, and internal audits.
- Review audit observations related to production and ensure timely implementation of corrective and preventive actions.
- Promote a quality-driven culture and ensure that product quality is never compromised to achieve production targets.

**C. Productivity Improvement and Operational Excellence**

- Drive continuous improvement initiatives to enhance manufacturing productivity, operational efficiency, and equipment utilization.
- Monitor key performance indicators such as Overall Equipment Effectiveness (OEE), batch cycle time, yield, rejection rate, and manpower productivity.
- Identify opportunities to reduce manufacturing losses, material wastage, equipment downtime, and process inefficiencies.
- Implement Lean Manufacturing, 5S, Kaizen, and other operational excellence initiatives.
- Optimize manufacturing processes to improve throughput and reduce overall conversion costs.
- Review equipment performance and coordinate with Engineering and Maintenance teams to ensure maximum equipment availability.
- Analyze recurring operational issues and implement sustainable improvement measures.
- Encourage employee participation in productivity improvement and cost optimization initiatives.

**D. Quality Management and Documentation**

- Ensure proper preparation, execution, review, and completion of manufacturing and packaging documentation.
- Monitor batch documentation practices to ensure accuracy, completeness, traceability, and compliance with approved procedures.
- Ensure timely investigation and documentation of manufacturing deviations, process failures, and non-conformances in coordination with Quality Assurance.
- Participate in root cause analysis and ensure effective implementation of corrective and preventive actions.
- Coordinate with QA and QC for process-related investigations, product quality issues, and batch release requirements.
- Ensure execution of process validation, cleaning validation, and other applicable validation activities as per approved protocols.
- Participate in Annual Product Quality Review (APQR/PQR) and identify opportunities for manufacturing process improvement.
- Ensure proper implementation of change controls and assess their impact on manufacturing operations.

**E. Manpower Management and Leadership Development**

- Lead, guide, and motivate production managers, assistant managers, officers, supervisors, and shop-floor personnel.
- Define departmental responsibilities, establish performance objectives, and monitor individual and team performance.
- Ensure optimum manpower utilization and effective deployment of personnel across shifts and manufacturing activities.
- Identify training needs and ensure regular training on GMP, SOPs, safety, equipment operation, and manufacturing procedures.
- Develop leadership capabilities among subordinate managers and supervisors.
- Conduct periodic performance reviews and provide constructive feedback to team members.
- Promote discipline, accountability, teamwork, and a culture of continuous improvement.
- Ensure availability of adequately trained and qualified personnel for all critical manufacturing activities.
- Support succession planning and development of second-line leadership within the production department.

**F. Cost Control and Resource Optimization**

- Develop and implement strategies to reduce manufacturing costs without compromising product quality or regulatory compliance.
- Monitor consumption of raw materials, packaging materials, utilities, and other manufacturing resources.
- Identify opportunities to reduce process losses, material wastage, rejection, and reprocessing.
- Ensure optimum utilization of manpower, equipment, utilities, and production facilities.
- Monitor manufacturing cost trends and identify areas requiring operational improvement.
- Participate in departmental budgeting and ensure effective control of operational expenditure.
- Implement cost-saving initiatives and evaluate their effectiveness through measurable performance indicators.

**G. Cross-Functional Coordination**

- Maintain effective coordination with Quality Assurance, Quality Control, Engineering, Maintenance, Warehouse, PPC, Regulatory Affairs, HR, EHS, and other relevant departments.
- Coordinate with PPC to ensure production priorities and delivery commitments are achieved.
- Work closely with QA and QC to resolve quality-related issues and ensure compliance with established quality systems.
- Coordinate with Engineering for equipment maintenance, breakdown resolution, preventive maintenance, and facility improvement activities.
- Support Regulatory Affairs during inspections, product registrations, and regulatory compliance activities.
- Coordinate with HR for manpower planning, recruitment, training, performance management, and employee development.
- Participate in management review meetings and present production performance, operational challenges, and improvement plans.

**H. Safety, Health, and Environmental Compliance**

- Ensure implementation of occupational health, safety, and environmental requirements within manufacturing operations.
- Promote safe working practices and ensure compliance with established EHS procedures.
- Ensure appropriate handling, storage, and disposal of chemicals, hazardous materials, and manufacturing waste.
- Monitor safety incidents, unsafe conditions, and near-miss events and ensure implementation of corrective actions.
- Ensure personnel are adequately trained in emergency response, workplace safety, and equipment handling.
- Promote a safe, hygienic, and disciplined working environment across all production areas.

**I. New Product Introduction and Technology Transfer**

- Support new product introduction, technology transfer, scale-up, and process optimization activities.
- Coordinate with R&D, Technology Transfer, QA, QC, and Engineering teams for successful product commercialization.
- Ensure manufacturing readiness in terms of equipment, manpower, documentation, utilities, and infrastructure.
- Participate in engineering batches, exhibit batches, validation batches, and commercial manufacturing activities.
- Identify and resolve process-related challenges during product scale-up and commercial manufacturing.
- Ensure successful transfer of manufacturing processes from development to commercial production in accordance with approved procedures.

3\. Key Performance Indicators (KPIs)

The performance of the DGM – Production will be evaluated based on the following parameters:

- Achievement of monthly and annual production targets.
- Improvement in manufacturing productivity and equipment utilization.
- Reduction in manufacturing cost, material wastage, and process losses.
- Improvement in Overall Equipment Effectiveness (OEE).
- Reduction in batch manufacturing cycle time and production delays.
- Compliance with cGMP and applicable regulatory requirements.
- Timely completion and accuracy of BMRs and BPRs.
- Timely closure of production-related deviations and CAPAs.
- Reduction in manufacturing rejection and reprocessing.
- Effective manpower utilization and training compliance.
- Successful execution of process validation and improvement projects.
- Reduction in safety incidents and improvement in workplace safety.

4\. Educational Qualification and Experience

- B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc. in a relevant scientific discipline.
- Approximately 15–20 years of relevant experience in pharmaceutical manufacturing, preferably with substantial experience in managerial roles.
- Experience in handling large-scale pharmaceutical manufacturing operations.
- Strong exposure to cGMP, Schedule M, WHO-GMP, and other applicable regulatory requirements.
- Experience in handling regulatory inspections, customer audits, and internal quality audits.
- Demonstrated experience in production planning, process optimization, cost reduction, and team management.
- Experience in handling manufacturing documentation, deviations, CAPA, change controls, and validation activities.

5\. Technical and Managerial Competencies

- Strong knowledge of pharmaceutical manufacturing processes and equipment.
- Good understanding of GMP, quality systems, regulatory requirements, and data integrity.
- Expertise in production planning, resource management, and capacity utilization.
- Knowledge of process validation, cleaning validation, and manufacturing investigations.
- Strong analytical, problem-solving, and decision-making capabilities.
- Excellent leadership, communication, and interpersonal skills.
- Ability to manage cross-functional teams and resolve operational challenges.
- Knowledge of Lean Manufacturing, 5S, Kaizen, and continuous improvement methodologies.
- Strong focus on quality, productivity, compliance, and business performance.

6\. Key Expected Outcomes

The DGM – Production is expected to ensure consistent achievement of production targets, improved manufacturing efficiency, optimum resource utilization, reduced operational costs, and sustained GMP compliance. The incumbent must develop a competent and accountable production team, establish a culture of operational excellence, and ensure that all manufacturing activities are conducted safely, efficiently, and in accordance with approved quality standards and regulatory requirements.

**Overall Accountability:** The Deputy General Manager – Production will be accountable for the overall performance of the production department, ensuring the timely manufacture of quality pharmaceutical products in compliance with regulatory requirements while achieving organizational objectives relating to productivity, cost efficiency, operational excellence, and customer satisfaction.