Validation Specialist

Would you like to work on something truly meaningful? How about joining a biotech startup that develops a revolutionary invention?

 

At intoDNA we have developed STRIDE, the first platform technology for direct detection of DNA damage. It has been successfully used by leading biotech and pharmaceutical companies and renowned academic groups to accelerate their drug development efforts.

We’re now working intensively to gain compliance with Good Clinical Practice. It involves a close collaboration between the Science and the IT Team to develop a consistent and secure process of delivering the best service to our customers.

For this reason, we’re looking for a Validation Specialist with a great interest in both Science and Technology.

Your job would be to author a set of GCP validation documents and test scenarios. You will conduct tests on intoDNA’s Computerized Systems to ensure their completeness and compliance with GCP requirements and regulations. You will also work closely with the IT Team, and consult their solutions to help verify if they answer the exact needs of our Science Team in the field of image analysis.

Location

Poland, Cracow

Responsibilities

  • Provide Quality Assurance for IT Systems at intoDNA
  • Conduct Validation of intoDNA IT Systems to reach compliance with Good Clinical Practice
  • Plan and coordinate efforts of multiple teams involved in GCP compliance projects
  • Participate in gathering Business Requirements for internal IT solutions
  • Author and review test scripts & validation documents
  • Own IT Systems change control management and periodic review processes
  • Participate in shaping the process of Quality Management in the organisation
  • Participate in vendor qualification, manage relations with 3rd party suppliers in the light of GCP compliance

Requirements

Essential

  • Experience in managing Good Clinical Practice (or GxP) processes
  • Bachelor’s (or higher) degree in Life Science or Engineering
  • Great project management skills
  • Eagerness to learn and understand problems to the core
  • Ability to translate complex technical concepts into a clear copy
  • Ability to plan and prioritize your work
  • A strong command of English, written and spoken (C1 level)
  • Attention to detail

Nice to have

  • Expertise in Computerized Systems Validation
  • Working experience in the Science field

What you can expect

  • Opportunity to make a real impact in an early-stage, highly innovative company
  • Collaborative work in stimulating and friendly environment
  • Professional development support
  • Flexible work approach
  • Comprehensive benefits package, including private medical healthcare and English classes

What you can expect

  • Opportunity to make a real impact in an early-stage, highly innovative company
  • Collaborative work in stimulating and friendly environment
  • Professional development support
  • Flexible work approach
  • Comprehensive benefits package, including private medical healthcare and English classes

Submit Your Application

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