Experience: Typically 8–15 years

1. Job Purpose

The QC Manager is responsible for overseeing all quality control activities related to raw materials, in -process materials, and finished medical devices to ensure compliance with regulatory standards, GMP, and internal quality systems.

Key Responsibilities

Quality Control Operations

• Manage QC testing of raw materials, in -process samples, and finished products.
  
• Ensure compliance with GMP, GLP, ISO standards, and regulatory guidelines.
  
• Review and approve QC test results and batch release documentation.
  
• Maintain and improve laboratory systems and testing procedures.
  

Documentation & Compliance

• Ensure QC documentation, SOPs, and records are properly maintained and updated.
  
• Review and approve change control, deviation reports, and investigation reports.
  
• Maintain laboratory compliance with regulatory audits and inspections.
  

Quality Systems

• Monitor calibration, validation, testing, and inspection activities.
  
• Ensure quality requirements are met during production and process control.
  
• Support CAPA (Corrective and Preventive Action) implementation.
  

Investigation & Troubleshooting

• Investigate OOS (Out of Specification) and OOT (Out of Trend) results.
  
• Identify root causes and implement corrective actions.
  
• Ensure product quality is maintained throughout manufacturing.
  

Team Management

• Lead and supervise QC analysts and officers.
  
• Provide training on SOPs, testing methods, and compliance procedures.
  
• Coordinate with QA, Production, and Regulatory teams.
  

Key Skills

• Quality systems management
  
• Laboratory operations
  
• CAPA & deviation management
  
• Regulatory compliance
  
• Documentation & audit readiness
  
• Team leadership
  

Requirements

Required Qualifications

• B.Sc / M.Sc / B.Pharm / M.Pharm or related science field
  
• 8–15 years experience in QC in pharma or medical devices
  
• Knowledge of
  • GMP / GLP
    
  • ISO 13485
    
  • Regulatory compliance (CDSCO / FDA / CE)
    
  • Analytical instruments and lab systems