Description
JOB DESCRIPTION
The role is responsible for ensuring real-time compliance with global GMP (Positive Manufacturing Practices) across manufacturing, packing, and dispensing operations. The role provides on-floor quality oversight, ensuring that all activities are executed as per approved procedures, regulatory expectations, and internal quality standards. The role performs line clearance, in-process checks, environmental monitoring, and documentation review, ensuring data integrity, product quality, and patient safety. The role actively supports cleaning validation, process validation, aseptic process simulations, and deviation management, while maintaining robust coordination with production, quality control, and engineering teams to ensure right-first-time manufacturing and inspection readiness.

Essential Functions
Perform IPQA (In-Process Quality Assurance) activities during manufacturing and packing operations
To conduct Sampling of reserve sample, stability sample and In-process checks during execution of batch packaging as per Batch Packaging Record (BPR)



and stability study protocol
To Issuance of Bottle label, Ouster and Medication guide for commercial batch
Oversee the Calibration of IPQA instruments
Execute and document Line Clearance and Readiness for manufacturing, packing, and dispensing areas
Conduct 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 completeness and accuracy
Monitor Environmental Monitoring and routine manufacturing area compliance
Ensure assurance of cleaning, sterilization, and aseptic manipulations
Perform Sampling of Cleaning Validation and compile records
Support Process Validation Reports (PVR – Process Validation Report) activities
Participate in Aseptic Process Simulation (Media

📌 Senior Officer, Ipqa Dahej
🏢 Amneal Pharmaceuticals
📍 Dahej