Officer, IPQA

1 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.
Additional Responsibilities:

• Ensure strict compliance with EHS policies, SOPs, and all applicable statutory and company safety requirements.
• Identify, report, and support the closure of unsafe conditions, unsafe acts, near misses, and incidents in a timely manner.
• Consistently use the prescribed Personal Protective Equipment (PPE) and maintain safe housekeeping practices within the work area.
• Actively participate in safety trainings, emergency drills, risk assessments (HIRA/JSA), and promote a strong safety culture.

Qualifications

Education:

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

Experience:

• 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses: