Job Description Summary

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

• Ensure compliance with aseptic processing procedures and Annex 1 requirements.
• Support environmental monitoring and utility monitoring during manufacturing.
• Investigate production deviations, non-conformances, and equipment failures.
• Participate in CAPA, Change Control, Risk Assessment (FMEA), and root cause investigations.
• Support media fill studies and aseptic process simulations.

Team Leadership

• Supervise operators and technicians during all shifts.
• Allocate manpower according to production requirements.
• Conduct daily shift meetings and production handovers.
• Identify training needs and ensure operator qualification and periodic requalification.
• Monitor employee performance and promote continuous improvement.

Regulatory & Audit Support

• Support regulatory inspections (USFDA, MHRA, EU GMP, WHO, PIC/S, ANVISA, etc.).
• Present production records and department documentation during audits.
• Ensure timely closure of audit observations related to aseptic manufacturing.

Continuous Improvement

• Drive initiatives to improve:
  • OEE (Overall Equipment Effectiveness)
  • Batch cycle time
  • Productivity
  • Right First Time (RFT)
  • Equipment utilization
  • Reduction of interventions and downtime
• Participate in Lean Manufacturing, Six Sigma, and digital manufacturing initiatives.

Safety & EHS

• Ensure compliance with EHS and safety procedures.
• Promote safe work practices within aseptic manufacturing areas.
• Participate in incident investigations and implementation of corrective actions.