Officer, IPQA

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

• 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.

• 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 good written and verbal communication skills in English language.

Education:

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

Experience:

• 2 - 4 Years