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 solid safety culture.

📌 Officer, IPQA (India)
🏢 Amneal
📍 India