Role & responsibilities :
Oversee In-Process Quality Assurance (IPQA) activities during API manufacturing operations.
Ensure compliance with cGMP, SOPs, and regulatory guidelines.
Review and monitor BMR/BPR, logbooks, and process documentation.
Handle line clearances, in-process checks, and batch release activities.
Manage deviations, CAPA, change controls, and investigations.
Ensure adherence to quality systems and documentation practices.
Coordinate with Production, QC, and other departments for smooth process execution.
Prepare for and support regulatory audits such as USFDA, WHO, MHRA, and EDQM.
Drive continuous improvement initiatives in quality and compliance.