Validation Consultant

At-a-Glance:

Are you ready to build your career by joining a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? If so, our client is hiring a Validation Consultant.

Position Type:

• Contract
• On-Site
  
  
  

Required:

• Working knowledge of cGxP regulations, FDA 21 CFR Part 11, GAMP5, and data integrity principles.
• Experience supporting analytical instrument validation and computerized system qualification.
• Familiarity with SOP development, project management processes, and regulatory compliance documentation.
• Strong organizational skills with the ability to manage multiple tasks accurately and within deadlines.
• Effective communication and leadership skills, with experience collaborating across cross-functional teams.
  
  
  

Responsibilities:

• Lead and support analytical instrument validation and qualification activities for laboratory equipment and systems (LE&IS) in engineering, chemistry, and IT environments.
• Develop and manage validation documentation including Risk Management Reports, Validation Plans, Qualification Reports, Change Controls, Regulatory Assessments, and 21 CFR Part 11 Assessments.
• Ensure compliance with cGxP requirements, internal Quality System procedures, and applicable national and international regulations.
• Serve as project lead for cross-functional initiatives of moderate scope, coordinating activities and ensuring timely project execution.
• Maintain and archive approved validation documentation while mentoring junior team members and promoting data integrity best practices.
  
  
  

Get in Touch:

We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Komal at 862-390-7418 to learn more.

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