Role & responsibilities
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 Valuable 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 Fill) monitoring
Support Change Control & Deviation Management and CAPA (Corrective and Preventive Action) implementation
Conduct Routine GMP Inspections and review quality records of other departments

Preferred candidate profile

Education:
B. Pharm / B.Sc. / M.Sc.

Experience:
3 years or more in 3 - 8 Years

📌 Officer To Sr Officer Ipqa At Raks Pharma Pvt Ltd Dahej
🏢 Amneal Pharmaceuticals
📍 Dahej