Senior Executive, IPQA EM

Ensure compliance with cGMP and regulatory requirements by performing in-process quality assurance activities on the manufacturing and packaging shop floor.

Requirements

• Ensure cGMP and compliance review in the manufacturing shop floor and packing areas.
• Supervise dispensing activity of manufacturing shop floor and packing areas.
• Provide machine and area clearance.
• 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.
• Review online documents and records like equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records etc..
• Calibrate IPQA instruments.
• Participate 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.
• Have good written and verbal communication skills in English language.