Head Quality Control and Assurance

1. Quality Management System (QMS)

• Establish, maintain, and continually improve the

  Quality Management System

  in compliance with

  WHO-GMP

  ,

  EU-GMP

  , and

  Schedule M

  requirements.
• Review and approve

  SOPs

  ,

  Change Controls

  ,

  Deviations

  ,

  CAPA

  ,

  OOS/OOT

  , and

  Market Complaints

  .
• Conduct and oversee

  internal audits

  ,

  vendor audits

  , and follow-up for compliance.
• Ensure effective implementation of data integrity principles in QA and QC operations.
  

2. Regulatory Compliance & Inspections

• Prepare and lead the site for

  WHO-GMP

  ,

  EU-GMP

  , and

  national regulatory audits

  .
• Ensure timely submission and compliance of audit CAPAs.
  
• Stay updated on global regulatory changes and ensure readiness for audits by international agencies.
  

3. Documentation & Validation

• Review and approve

  Batch Manufacturing and Packaging Records (BMR/BPR)

  .
• Oversee

  equipment qualification

  ,

  process validation

  ,

  cleaning validation

  , and

  method validation

  activities.
• Maintain strict

  document control

  , record retention, and archival procedures in alignment with data integrity requirements.

4. Quality Control Oversight

• Supervise QC operations including

  Raw Material

  ,

  In-Process

  ,

  Finished Product

  ,

  Stability

  , and

  Microbiology

  testing.
• Approve analytical methods, specifications, and ensure

  calibration and validation

  of laboratory instruments.
• Review and approve test reports, ensuring accuracy, traceability, and compliance.
  

5. Continuous Improvement & Risk Management

• Lead

  Quality Risk Assessments (QRA)

  and implement preventive and corrective actions.
• Drive

  continuous improvement initiatives

  to enhance quality, efficiency, and regulatory compliance.
• Analyze

  quality trends

  and implement measures for performance enhancement.

6. Training & Team Leadership

• Develop, train, and mentor QA and QC teams to ensure high competency and regulatory awareness.
  
• Conduct

  GMP, GDP, and Data Integrity

  training sessions across departments.
• Foster a culture of quality and accountability throughout the organization.
  

Key Skills and Competencies:

• Comprehensive knowledge of

  WHO-GMP

  ,

  EU-GMP

  , and

  ICH Q-series guidelines

  .
• Strong expertise in

  QMS, validation, audits, and documentation systems

  .
• Proven ability to handle

  regulatory inspections

  and

  customer audits

  .
• Leadership, analytical thinking, and decision-making capabilities.
  
• Excellent communication and cross-functional coordination skills.