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