Lead Validation Expert

2 days ago

Kottayam, Kerala, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Description

We are seeking a skilled Lead Validation Expert to support global projects remotely, ensuring compliance with FDA, EU, and international regulations.

This role involves preparing, executing, and managing validation documentation for new and existing facilities, utilities, systems, and equipment.

  • Manage CQV activities for manufacturing equipment, utilities, and computerized systems in line with regulatory standards.
  • Develop and review validation documentation, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments.
  • Implement validation master plans and system impact assessments, collaborating with cross-functional teams.
  • 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 meets GAMP 5, FDA, EMA, and ISO 13485 requirements.
  • Oversee remote execution of validation test protocols, capturing and resolving deviations.
  • Drive continuous improvement and risk-based validation strategies aligning with industry best practices.
Required Skills and Qualifications:
  • Strong knowledge of GxP regulations and industry standards.
  • Excellent leadership and communication skills.
  • Ability to work independently and manage multiple projects.
Benefits:
  • Opportunity to work with a global team.
  • Chance to develop and implement validation strategies.
Others:

The ideal candidate will have experience working in a similar role and a strong understanding of validation principles. If you are a motivated professional looking for a new challenge, please apply.

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