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