Senior Group Lead - Manufacturing & Filling Operations

Job Summary :

Responsible for leading and overseeing manufacturing and aseptic filling operations for Complex Injectable products, including Emulsions, Suspensions, and Microsphere formulations.

The role involves managing production activities, batch planning, manpower utilization, equipment qualification reviews, documentation compliance, electronic systems (MES/SAP), and ensuring adherence to cGMP, Data Integrity, and regulatory requirements.

The incumbent shall drive operational excellence while maintaining product quality, compliance, safety, and schedule adherence.

Key Responsibilities:

Manufacturing & Filling Operations

• Lead and supervise manufacturing and aseptic filling activities for complex injectable products.
• Ensure execution of manufacturing operations as per approved Batch Manufacturing Records (BMRs) and SOPs.
• Monitor critical process parameters and ensure compliance with established process controls.
• Support scale-up and validation, and process optimization activities.
• Coordinate production schedules to meet monthly and annual business plans.
• Ensure timely batch execution while maintaining quality and compliance requirements.

Batch Planning & Production Scheduling

• Prepare weekly and monthly batch plans.
• Optimize equipment utilization and resource allocation.
• Coordinate with Warehouse, Quality Assurance, Quality Control, Engineering, Validation, and Supply Chain teams.
• Monitor batch progress and ensure timely completion.
• Drive adherence to production schedules and customer demand requirements.

Product Knowledge & Technical Expertise

Must possess strong technical knowledge of:

• Emulsion Products
• Homogenization processes
• Mixing and emulsification parameters
• Process troubleshooting
• Suspension Products
• Particle size reduction
• Mixing and agitation strategies
• Filtration and transfer operations
• Microsphere Products
• Solvent evaporation techniques
• Drying operations
• Particle size control and yield optimization
• Aseptic Filling Operations
• Oversee aseptic filling line operations and associated equipment.
• Ensure compliance with aseptic techniques and contamination control strategies.
• Monitor line performance, interventions, and process simulations.
• Support media fill execution and qualification activities.
• Ensure compliance with Annex 1 and aseptic processing requirements.

Equipment Qualification & Validation

Review and support:

• Equipment commissioning and qualification activities
• Requalification activities
• Change Controls
• Risk Assessments
• Validation Protocols and Reports
• Ensure equipment remains in qualified state throughout its lifecycle.

Documentation & Compliance

Review and approve:

• Batch Manufacturing Records (BMR)
• Equipment Logbooks
• Cleaning Records
• SOPs
• Change Controls
• Deviations
• CAPAs
• Risk Assessments

Ensure compliance with:

• cGMP
• Data Integrity (ALCOA+)
• USFDA
• EU GMP Annex 1
• MHRA
• WHO GMP requirements
• Support internal and external audits and regulatory inspections.

Manpower Management

• Lead and manage shift supervisors, operators, and technicians.
• Prepare manpower deployment plans based on production requirements.
• Conduct performance evaluations and competency assessments.
• Identify training needs and ensure continuous skill development.
• Drive employee engagement and accountability within the team.
• Ensure compliance with safety and GMP practices.

Continuous Improvement

• Lead Lean Six Sigma, Kaizen, and productivity improvement initiatives.
• Yield improvement
• Cycle time reduction
• Batch size optimization
• Cost reduction
• Digital transformation

Monitor and improve KPIs related to productivity, quality, and compliance