Senior CSV Validation Specialist

3 weeks ago


Raritan, New Jersey, United States Tekfortune Inc Full time

At Tekfortune Inc, we are seeking a highly skilled Senior CSV Validation Specialist to join our team of experts in the pharmaceutical industry.

The ideal candidate will have a strong background in system development lifecycle, computer system validation, and FDA regulations. They will be responsible for performing qualitative and quantitative analyses to assist in the identification of client issues and the development of client-specific solutions.

The successful candidate will have experience in writing and executing documentation for all aspects of validation deliverables, including requirements, compliance validation plans, test protocols, and compliance validation reports. They will also be able to review system test and user acceptance test scripts, traceability matrices, and design specs.

We are looking for a team player who can work independently and guide junior resources. The ideal candidate will have strong verbal and written communication skills, as well as the ability to work with remote teams and support multiple projects simultaneously.

The responsibilities of this role include:

  • Developing and delivering detailed solutions through consulting project activities
  • Performing qualitative and quantitative analyses to assist in the identification of client issues and the development of client-specific solutions
  • Working with the team to implement solutions
  • Developing good practice and serving as a subject matter expert
  • Designing and structuring reports and presentations that are appropriate to the characteristics or needs of the audience
  • Developing a knowledge base by staying updated on industry best practices, emerging trends, and creating re-usable components

For more information, please contact our recruitment team at Tekfortune Inc.



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