GRANULATION OPERATOR

Job Title: Granulation Operator

Department: Manufacturing / Production
Location: [Insert Location]
Reports To: Production Supervisor / Manufacturing Manager
Employment Type: Full-time

Job Summary:

The Granulation Operator is responsible for performing granulation activities as per the batch manufacturing records (BMR) and standard operating procedures (SOPs) in a cGMP-compliant pharmaceutical manufacturing facility. The role ensures the accurate processing of raw materials into granules used for tablet and capsule production.

Key Responsibilities:

• Operate granulation equipment such as high shear mixer, fluid bed dryer (FBD), multi-mill, oscillating granulator, sifter, and blenders.
• Review and follow batch manufacturing records (BMR), SOPs, and GMP guidelines.
• Perform equipment set-up, cleaning, and changeover as per defined procedures.
• Monitor granulation parameters such as mixing time, binder addition, drying time, and temperature.
• Accurately record data in logbooks and BMRs.
• Coordinate with QA/QC for in-process sampling and approvals.
• Ensure proper usage and handling of raw materials and granulated intermediates.
• Maintain cleanliness and hygiene in the granulation area at all times.
• Troubleshoot minor equipment issues and report maintenance needs promptly.
• Participate in deviation reporting, investigations, and CAPA implementation.
• Adhere to EHS (Environment, Health & Safety) regulations.

Required Qualifications:

• Education: ITI / Diploma in Pharmacy / B.Sc / M.Pharm or equivalent
• Experience: 1–3 years of experience in granulation operations within a pharmaceutical (formulations) environment
• Knowledge:
• Understanding of granulation processes (dry and wet)
• Working knowledge of cGMP, GDP, and EHS guidelines
• Familiar with regulatory requirements (USFDA, EU, WHO)

Skills & Competencies:

• Ability to read and interpret SOPs and BMRs
• Basic mechanical aptitude for equipment operation
• Attention to detail and accuracy in documentation
• Good communication and teamwork skills
• Time management and ability to work in shifts

Working Conditions:

• Shift-based work (Day/Night)
• Exposure to noise, powders, and temperature-controlled environments
• Requires wearing PPE (Personal Protective Equipment)

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Job Types: Full-time, Permanent

Schedule:

• Rotational shift

Work Location: In person