Description
Description:
The role involves supervising aseptic manufacturing activities, ensuring adherence to GMP (Valuable Manufacturing Practices) and GDP (Positive Documentation Practices) across General, Control, and Aseptic areas. The position is accountable for equipment and line validation status, change control, deviation management, and CAPA (Corrective and Preventive Action) implementation. The role also leads SOP (Standard Operating Procedure) lifecycle management, production planning versus actual performance monitoring, and regulatory readiness. Additionally, the role requires maintaining accurate online documentation systems and aligning operations with USFDA (United States Food and Drug Administration) and ICH (International Council for Harmonisation) requirements.

Essential Functions:
Ensure and monitor all GMP (Valuable Manufacturing Practices) and GDP (Good Documentation Practices) activities, including cleaning and sanitization, across General, Control, and Aseptic areas
Supervise overall injectable manufacturing operations during assigned shifts,



ensuring aseptic compliance
Ensure all equipment and manufacturing lines are validated and calibrated as per approved schedules
Generate and track general purchase indents for departmental consumables and production items
Handle Change Control, Deviations, Investigations, and CAPA (Corrective and Preventive Action) in coordination with QA
Prepare, review, revise, control, and implement SOPs (Standard Operating Procedures) for sterile manufacturing operations
Prepare production plan vs actual reports on daily and monthly basis based on material availability
Ensure strict adherence to aseptic techniques and sterilization processes during injectable manufacturing
Monitor CPPs (Critical Process Parameters) and CQAs (Critical Quality Attributes) during batch execution
Support internal and external audits and ensure compliance with USFDA and ICH guidelines
Responsible for preparation & review of th

📌 Manager, Manufacturing Injectables Sanand (India)
🏢 Amneal
📍 India