(JD)

Section In-Charge – Granulation

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:

Rapid Mixer Granulator (RMG)

Fluid Bed Dryer (FBD)

Multi Mill

Vibro Sifter

Blender

Coordinate preventive maintenance and calibration activities.

Ensure equipment qualification status is maintained.

Safety, Health & Environment

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.

Continuous Improvement

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

Solid 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)

Production plan adherence ≥ 95%

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

📌 Manager (India)
🏢 Emcure Pharmaceuticals
📍 India