Description
Description:
The role is responsible for ensuring day-to-day compliance with global GMP (Positive Manufacturing Practices) during manufacturing, packing, and dispensing activities at the site. The role provides on-floor quality assurance support, ensuring operations are performed as per approved procedures, validated processes, and regulatory expectations. The role performs line clearance, in-process checks, routine area monitoring, and documentation review, ensuring data integrity, product quality, and patient safety. The position supports cleaning validation, process validation, and aseptic process simulations, and assists in deviation management and inspection readiness, contributing to consistent, compliant, and right-first-time pharmaceutical manufacturing.

Essential Functions:
Perform IPQA (In-Process Quality Assurance) activities during manufacturing and packing operations
Oversee calibration of IPQA instruments
Review of and release of Batch
Review the in-process and finished product COA before batch release




Keeping records & review of equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records
Execute Line Clearance and Readiness for manufacturing, packing, and dispensing areas
Conduct routine In-Process Checks and coordinate with IPQC (In-Process Quality Control)
Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations – Current Positive Manufacturing Practice for Drugs)
Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy
Perform Environmental Monitoring and routine monitoring of manufacturing areas
Ensure assurance of cleaning, sterilization, and aseptic manipulations
Support Sampling of Cleaning Validation and record compilation
Assist in Process Validation Reports (PVR – Process Validation Report) activities
Support Aseptic Process Simulation (Media Fill) monitoring
Ensure Valuable Documentation Practices (

📌 Executive, Ipqa Sanand
🏢 Amneal
📍 Sanand