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
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