Officer, IPQA

Description

• cGMP and compliance review in the GMP area as per cGMP guideline.

2 Machine and area clearance.

3 Sampling of blend, intermediate stages, AQL finished product, ANSI sample, reserve sample, stability sample and In-process checks during execution of batch manufacturing & Packaging as per Process Study Protocol (PSP), Process Validation Protocol (PVP), Batch Manufacturing Record (BMR), Batch Packaging Record (BPR) & miscellaneous protocol based study.

4 Issuance of Bottle label, Outsert and Medication guide for commercial batch.

5 Documents and records review like equipment logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record etc.

6 Calibration of IPQA instruments.

7 Supervision of dispensing activity of raw material and packaging material.

8 Review of executed Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR) and release for next stage.

Education

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience

• 2 years or more in 2 - 5 Years

Specialized Knowledge

Licenses