Manager

Emcure Pharmaceuticals Limited; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Emcure Pharmaceuticals Limited in Pune is seeking an experienced Section In-Charge – Granulation to manage granulation operations in line with cGMP, SOPs, and quality standards. You will ensure timely production plans, optimal manpower and equipment utilization, and regulatory compliance.

Leading a team of operators, you will oversee end-to-end granulation processes, drive safety, data integrity, and continuous improvement initiatives such as Lean manufacturing and OEE trends, while coordinating

Qualifications

• 8-12 years of experience in pharmaceutical manufacturing, preferably in OSD production.
• Minimum 3-5 years of experience handling Granulation operations independently.
• Exposure to regulatory audited facilities ( MHRA, EU-GMP, WHO-GMP, ANVISA) is preferred.

Responsibilities

• Execute daily production plans for granulation activities as per approved schedules.
• Ensure dispensing, sifting, blending, granulation, drying, milling, and related processing activities are performed as per BMR/BPR and SOPs.
• Monitor critical process parameters and ensure compliance with validated processes.
• Ensure optimum machine utilization and productivity targets are achieved.
• Coordinate with Planning, Warehouse, Engineering, QA, and QC departments for uninterrupted operations.
• Lead a team of operators, technicians, and line supervisors.
• Allocate manpower effectively across shifts and activities.
• Conduct shift handovers and review production progress.
• Train and develop team members on GMP, SOPs, Safety, and Data Integrity requirements.
• Drive discipline, attendance, and performance management within the section.
• Review BMR entries and ensure accurate documentation practices.
• Investigate deviations, incidents, OOS/OOT observations, and implement CAPA.
• Support internal audits, customer audits, and regulatory inspections including USFDA, MHRA, EU-GMP, WHO-GMP, ANVISA.
• Monitor and improve KPIs such as: Batch yield, OEE, Right First Time, and wastage reduction.

Skills

Granulation

Leadership

Manpower management

cGMP

GDP

Data Integrity

Regulatory requirements

SAP

MES

Communication

Education

B.Pharm / M.Pharm

Tools

SAP

MES

Job description

Department: Production - Oral Solid Dosage (OSD)

Experience: 8-12 Years

Reporting To: Head production

Position Summary

The Section In-Charge – Granulation is responsible for managing and supervising granulation operations in compliance with cGMP, SOPs, Data Integrity, EHS, and quality requirements. The role ensures timely execution of production plans, optimum utilization of manpower and equipment, adherence to regulatory requirements, and achievement of productivity and quality targets.

Key Responsibilities

Production Operations

• Execute daily production plans for granulation activities as per approved schedules.
• Ensure dispensing, sifting, blending, granulation, drying, milling, and related processing activities are performed as per BMR/BPR and SOPs.
• Monitor critical process parameters and ensure compliance with validated processes.
• Ensure optimum machine utilization and productivity targets are achieved.
• Coordinate with Planning, Warehouse, Engineering, QA, and QC departments for uninterrupted operations.

Team Management

• Lead a team of operators, technicians, and line supervisors.
• Allocate manpower effectively across shifts and activities.
• Conduct shift handovers and review production progress.
• Train and develop team members on GMP, SOPs, Safety, and Data Integrity requirements.
• Drive discipline, attendance, and performance management within the section.

Quality & Compliance

• Ensure strict compliance with cGMP, GDP, Data Integrity, and regulatory requirements.
• Review BMR entries and ensure accurate documentation practices.
• Investigate deviations, incidents, OOS/OOT observations, and implement CAPA.
• Support internal audits, customer audits, and regulatory inspections including USFDA, MHRA, EU-GMP, WHO-GMP, ANVISA, etc.
• Ensure adherence to cleaning validation and line clearance procedures.

Equipment & Maintenance

• Monitor performance of granulation equipment such as:
• Coordinate preventive maintenance and calibration activities.
• Ensure equipment qualification status is maintained.
• Ensure compliance with plant EHS procedures.
• Conduct safety observations and risk assessments.
• Promote near-miss reporting and implementation of corrective actions.
• Ensure proper use of PPE and safe work practices.
• Drive initiatives related to productivity, yield improvement, cycle time reduction, and wastage reduction.
• Participate in Lean Manufacturing, Kaizen, and operational excellence projects.
• Monitor and improve KPIs such as:
• Batch completion adherence
• Right First Time (RFT)
• Yield
• OEE
• Deviation trends
• Manpower productivity

Educational Qualification

• B.Pharm / M.Pharm

Required Experience

• 8-12 years of experience in pharmaceutical manufacturing, preferably in OSD production.
• Minimum 3-5 years of experience handling Granulation operations independently.
• Exposure to regulatory audited facilities ( MHRA, EU-GMP, WHO-GMP, ANVISA) is preferred.

Required Skills

• Strong knowledge of cGMP, GDP, Data Integrity, and regulatory requirements.
• Expertise in granulation and powder processing operations.
• Strong leadership and manpower management skills.
• Knowledge of batch document review and investigation handling.
• Good analytical and problem-solving abilities.
• SAP/MES exposure preferred.
• Excellent communication and coordination skills.

Key Performance Indicators (KPIs)

• Batch yield compliance
• Zero critical GMP violations
• Reduction in deviations and market complaints
• Training compliance of team members
• OEE and productivity improvement
• Safety compliance and accident-free operations