CSV Validation Specialist

1 week ago

Bikaner, Rajasthan, India SpurQLabs | Next-Generation Software Testing & Test Automation Services Full time

About the Role

We are seeking a talented CSV Validation Specialist to join our team at SpurQLabs | Next-Generation Software Testing & Test Automation Services. As a CSV Validation Specialist, you will play a critical role in ensuring the quality and reliability of computerized systems within the pharmaceutical industry.

Key Responsibilities

  • Computer System Validation (CSV):
  • Lead validation activities for computerized systems, ensuring compliance with FDA, GMP, GLP, and 21 CFR Part 11 regulations.
  • Perform validation tasks across various systems.
  • Ensure the development and execution of key deliverables, including validation plans, system requirements specifications, requirements traceability matrices, software installation documentation, operational qualification protocols, and performance qualification scripts.
  • Compile validation activities and results into a comprehensive validation summary report, providing a final assessment of the system's compliance and fitness for use.

Qualifications

  • Education:
  • Bachelor's degree in Computer Science, Engineering, Biotechnology, Life Sciences, or a related technical field.
  • Experience:
  • Minimum of 2.5-5 years of experience in CSV validation within the pharmaceutical, medical device, or biotech industry.
  • Extensive experience in preparing and executing validation deliverables, including validation plans, IQ/OQ/PQ protocols, and validation summary reports.
  • Knowledge of regulatory guidelines and compliance standards, such as FDA, GMP, GLP, and 21 CFR Part 11.
  • Proven experience with various computerized systems used in laboratories and production environments.

Working with Us

At SpurQLabs, we are dedicated to helping our clients build exceptional quality products at speed. Our team of experts is passionate about delivering next-generation software testing and test automation services. If you are a motivated and detail-oriented individual who is passionate about ensuring the quality and reliability of computerized systems, we encourage you to apply for this exciting opportunity.

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