Description:

To ensure compliance with cGMP and regulatory requirements by performing
in-process quality assurance activities on the manufacturing and packaging shop
floor, including real-time monitoring, documentation review, sampling, and
area/machine clearances, thereby supporting the production of high-quality
injectable pharmaceutical products

Essential Functions:
* To ensure cGMP and compliance review in the manufacturing shop floor and
packing areas.

* To supervision of dispensing activity of manufacturing shop floor and packing
areas.

* To Issuance of Bottle label, Ouster and Medication guide for commercial
batch.

* Rsponsible for providing machine and area clearance.

* 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.

* Online Documents and records review like equipment’s logbooks, dispensing
logs, housekeeping records, environmental monitoring records, calibration
record, batch records etc..

* Calibration of IPQA instruments.

Additional Responsibilities:
* Real-time Monitoring and Compliance Reporting.

* Participation in Investigations.

* Provide on-the-job training to shop floor personnel on GMP practices, quality
standards, and documentation practices.

* Maintain IPQA-related documents and records in a state of audit readiness.

* To have valuable written and verbal communication skills in English language.

📌 Executive, IPQA (Ahmedabad)
🏢 Amneal India
📍 Ahmedabad