- Shop Floor Oversight: Conduct regular monitoring of manufacturing and packaging operations to ensure compliance with Positive Manufacturing Practices (GMP).
- In-Process Checks: Perform physical inspections and tests—such as weight variation, hardness, and friability—at defined intervals during production.
- Line Clearance: Verify and authorize the "Line Clearance" before starting any new batch to prevent cross-contamination or mix-ups.
- Documentation Review: Audit Batch Production Records (BPR) and Batch Packaging Records (BPR) in real-time to ensure data integrity and accuracy.
- Environmental Monitoring: Monitor controlled environments, checking parameters like temperature, humidity, and pressure differentials in production areas.
- Sampling: Collect representative samples of raw materials, intermediates,
and finished products for laboratory analysis and stability testing.
- Deviation Management: Identify, document, and report any deviations or non-conformances on the floor, assisting in root cause investigations.
- Equipment Validation: Ensure all processing equipment and weighing scales are properly calibrated and labeled with their current status.
- Standard Operating Procedures (SOPs): Ensure all personnel strictly follow established SOPs and provide on-the-job training where necessary.
- Regulatory Compliance: Act as a quality gatekeeper to ensure the facility remains audit-ready for inspections by bodies like the FDA, MHRA, or WHO.
📌 IPQA - Supervisor (Vadodara)
🏢 USV
📍 Vadodara
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