Senior Executive, IPQA

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 good written and verbal communication skills in English language.