Job Description Summary
To supervise and coordinate aseptic filling and isolator operations for sterile injectable products, ensuring production targets are achieved while maintaining compliance with cGMP, aseptic practices, data integrity, and global regulatory requirements (USFDA, EU GMP, MHRA, WHO, PIC/S).
Job Description
Production Operations
Supervise daily aseptic filling and isolator operations as per the production schedule.
Ensure timely execution of batch manufacturing with optimum utilization of manpower and equipment.
Monitor critical process parameters and ensure adherence to approved Batch Manufacturing Records (BMR).
Coordinate with Planning, QA, QC, Engineering, Warehouse, and Validation to ensure uninterrupted operations.
Ensure proper line clearance before batch initiation and completion.
Isolator & Aseptic Process Management
Supervise operation of aseptic isolator systems and filling machines.
Ensure successful execution of VHP decontamination cycles.
Verify glove integrity testing before and after operations.
Monitor isolator pressure differentials, alarms,
environmental conditions, and system performance.
Ensure all aseptic interventions are performed using approved aseptic techniques.
Maintain compliance with the facility's Contamination Control Strategy (CCS).
Equipment Management
Supervise operation of:
Aseptic Filling Machines
Isolator Systems
Stoppering and Capping Machines
VHP Generators
CIP/SIP Systems
Nitrogen Purging Systems (where applicable)
Coordinate preventive maintenance and breakdown activities with Engineering.
Support equipment qualification (IQ/OQ/PQ), FAT/SAT, and commissioning activities.
Documentation & Compliance
Review Batch Manufacturing Records, equipment logbooks, and production documentation.
Ensure compliance with cGMP, GDP, ALCOA+, and Data Integrity requirements.
Verify accurate recording of process parameters and in-process checks.
Ensure timely review and closure of production documentation.
Quality Assurance
Ens
📌 Sr. Associate Manufacturing (Indore)
🏢 Endo
📍 Indore