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 positive written and verbal communication skills in English language.

Education:

- Bachelors Degree (BA/BS) B. Pharm - Required
- Master Degree (MS/MA) M. Sc. - Preferred
- Master Degree (MS/MA) M. Pharm - Preferred

Experience:

- 1 year or more in 2 - 4 Years

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