Team Member - Manufacturing (Granulation)

Purpose of the Role

To execute granulation manufacturing activities in accordance with approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), cGMP requirements, and safety standards, ensuring consistent production of high-quality pharmaceutical products while meeting productivity, compliance, and quality objectives.

Key Roles & Responsibilities

Raw Material Handling & Dispensing

• Verify availability and status of raw materials before batch execution.
• Receive and transfer dispensed materials as per BMR requirements.
• Check material identity, quantity, batch number, and status labels before use.
• Ensure proper handling and storage of materials during manufacturing.
Granulation Operations

• Perform sifting, dispensing, dry mixing, wet granulation, drying, milling, and blending activities as per approved procedures.
• Operate pharmaceutical manufacturing equipment such as:• Rapid Mixer Granulator (RMG)
• Fluid Bed Dryer (FBD)
• Fluid Bed Processor (FBP)
• Multi Mill
• Cone Mill
• Vibro Sifter
• Octagonal Blender / Bin Blender

• Monitor critical process parameters during manufacturing.
• Ensure product quality and process consistency throughout batch execution.
Equipment Operation & Maintenance

• Conduct machine startup, operation, shutdown, and cleaning activities.
• Perform pre-operation and post-operation equipment checks.
• Report equipment abnormalities and breakdowns immediately.
• Support preventive maintenance activities as required.
• Ensure equipment is used and maintained according to approved SOPs.
Batch Documentation

• Record manufacturing activities accurately in Batch Manufacturing Records (BMRs).
• Maintain equipment logbooks and operational records.
• Follow Good Documentation Practices (GDP) and Data Integrity requirements.
• Record process parameters, yields, and observations accurately and contemporaneously.
• Ensure all entries are complete and compliant with regulatory expectations.
In-Process Controls & Quality Compliance

• Perform and document in-process checks as defined in BMRs and SOPs.
• Monitor granulation quality parameters during processing.
• Coordinate with IPQA for line clearance and stage-wise approvals.
• Report deviations, non-conformances, and process abnormalities immediately.
• Support investigation activities by providing accurate data and observations.
Line Clearance & Area Compliance

• Perform line clearance before starting manufacturing operations.
• Verify cleanliness and readiness of equipment and manufacturing areas.
• Ensure proper status labeling of equipment, accessories, and materials.
• Prevent product mix-ups and cross-contamination.
Cleaning & Housekeeping

• Perform equipment cleaning and area cleaning as per approved cleaning procedures.
• Maintain housekeeping standards and 5S practices in production areas.
• Handle and dispose of manufacturing waste according to SOPs.
• Ensure manufacturing areas remain audit-ready and inspection-ready.
cGMP & Regulatory Compliance

• Adhere to cGMP guidelines and site quality systems.
• Follow approved SOPs, BMRs, and manufacturing instructions.
• Comply with regulatory requirements including USFDA, MHRA, WHO-GMP, and EU-GMP standards.
• Participate in internal audits and regulatory inspections.
• Ensure compliance with data integrity and quality systems.

Function: Other
Experience Level: Mid-Senior Level