Sr. Associate Manufacturing

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

• 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.