CQV Validation Lead

1 day ago

Udaipur, Rajasthan, India beBeeValidation Full time ₹ 1,32,07,000 - ₹ 1,98,10,000

Job Summary:

We are seeking an experienced CQV Validation Lead to support our global CQV projects remotely, ensuring compliance with FDA, EU, and other international regulations, including Good eXchange Practice (GxP) standards.

This role involves the preparation, execution, and lifecycle management of CQV documentation for new and existing facilities, utilities, systems, and equipment.

Key Responsibilities:
  • Lead and execute CQV activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory and industry standards.
  • Develop and review CQV documentation, including User Requirements Specification (URS), Design Qualification (DQ), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and risk assessments.
  • Manage and implement validation master plans (VMP) and system impact assessments.
  • Collaborate with cross-functional teams to ensure seamless CQV integration into capital and remediation projects.
  • Conduct remote FAT/SAT support, data review, and validation strategy planning.
  • Support Data Integrity assessments and 21 CFR Part 11 compliance for computerized systems.
  • Ensure documentation complies with GAMP 5, FDA, EMA, and ISO 13485 requirements.
  • Oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.
  • Drive continuous improvement and risk-based validation strategies in line with current industry best practices.
  • Mentor junior CQV engineers and act as a subject matter expert (SME) in audits and inspections.
Requirements:
  • Over 10 years of experience in CQV activities across the pharmaceutical and medical device sectors.
  • Proven expertise in preparing, executing, and managing CQV documentation.
  • Familiarity with regulatory and industry standards, including FDA, EU, and GxP.
  • Excellent communication and project management skills.
  • Ability to work independently and collaboratively as part of a team.
  • Strong analytical and problem-solving skills.
  • Bachelor's degree in a related field or equivalent experience.
What We Offer:
  • A dynamic and supportive work environment.
  • The opportunity to work on challenging projects and develop your skills.
  • A competitive salary and benefits package.
  • Professional development opportunities.
About Us:

We are a leading organization in the pharmaceutical and medical device sectors, committed to delivering high-quality products and services. Our team is dedicated to excellence and innovation, and we are always looking for talented individuals to join us.

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