Manager - Quality Assurance - IPQA (API)
Hetero · Sangareddy, Telangana, India
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Hetero · Sangareddy, Telangana, India
Key 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. Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.