Quality Assurance Head

This role is for one of the Weekday's clients

Salary range: Rs 1500000 (ie INR 15 LPA)

Min Experience: 10 years

Location: Himachal Pradesh

JobType: full-time

We are seeking a skilled professional to lead Equipment Qualification, Process Validation, and Quality Compliance initiatives within a regulated environment. The role involves ensuring that equipment, processes, and systems meet stringent regulatory standards, maintaining a robust Quality Management System (QMS), and managing validation documentation across multiple domains including water systems and cleaning procedures. This position also requires strong leadership and team management capabilities to effectively coordinate manpower and ensure compliance excellence.

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.