Senior Executive, IPQA EM
Job Description
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.
Education :
Master Degree (MS/MA) M. Sc - Microbiology
Experience:
2 years or more in 2 - 4 Years