Quality Assurance Head

This role is for one of the Weekday's clients

Salary range: Rs 1500000 (ie INR 15 LPA)

Equipment Qualification, Process Validation, and Quality Compliance

Requirements

Key Responsibilities:

• Lead and execute Equipment Qualification activities ensuring all critical equipment meets regulatory standards
• Conduct Process Validation for new and existing manufacturing processes, ensuring reproducibility and compliance
• Perform Water System and Cleaning Validations, documenting results and ensuring systems meet quality standards
• Prepare and review Risk Assessment documentation, identifying potential process or equipment risks and mitigation strategies
• Maintain and ensure adherence to Quality Management System (QMS) requirements, SOPs, and regulatory guidelines
• Manage, mentor, and coordinate team members, ensuring efficient manpower utilization and skill development
• Collaborate with cross-functional teams to ensure validation and compliance timelines are met
• Prepare, review, and maintain detailed validation protocols, reports, and regulatory documentation
• Drive continuous improvement initiatives to enhance process efficiency, compliance, and validation effectiveness
  

What Makes You a Great Fit:

• Strong hands-on experience in Equipment Qualification, Process Validation, Water System Validation, and Cleaning Validation
• Proven expertise in Risk Assessment and QMS operations within a regulated environment
• Ability to lead and manage teams, ensuring proper allocation of tasks and effective manpower handling
• Excellent communication skills to coordinate with internal teams and regulatory authorities
• Extensive knowledge of regulatory compliance and documentation standards
• Detail-oriented, organized, and proactive in maintaining compliance and operational excellence