Granulation Operator

2 days ago

Makarpura Vadodara Gujarat, India SHAIMIL LABORATORIES Full time

**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)

Let me know if you'd like this as a Word or PDF file, or if you want a version tailored to a specific dosage form (e.g., tablets, capsules, etc.).

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**Job Types**: Full-time, Permanent

Schedule:

- Rotational shift

Work Location: In person

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