Officer

Role Overview

Ensure compliance with cGMP and regulatory requirements by performing real-time quality assurance activities on the manufacturing and packaging shop floor. Key duties include monitoring production processes, reviewing documentation, conducting sampling for reserve/stability batches, managing area/machine clearances, calibrating instruments, and maintaining audit-ready records.

Essential Functions

• Maintain cGMP compliance in manufacturing and packing areas.
• Supervise dispensing activities on the shop floor.
• Issuance of Bottle labels, Ousters, and Medication guides for commercial batches.
• Manage machine and area clearance protocols.
• Conduct sampling (reserve, stability, in-process) per Batch Packaging Records (BPR).
• Review online documents including equipment logbooks, environmental monitoring records, calibration logs, and batch records.
• Calibrate IPQA instruments regularly.

Additional Responsibilities

• Perform real-time monitoring and submit compliance reports.
• Participate in quality investigations when required.
• Train shop floor personnel on GMP practices, standards, and documentation.
• Maintain all IPQA documents for audit readiness.