Manager- Quality Assurance (IPQA) @ Kazipalli
Hetero · Hyderabad, Telangana, India
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Hetero · Hyderabad, Telangana, India
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.