Computer System Validation Specialist

3 weeks ago


Baddi, Himachal Pradesh, India PQE Group Full time
About the Role

We are seeking a highly skilled Computer System Validation Specialist to join our team at PQE Group. As a Senior CSV Expert, you will play a critical role in supporting our projects in Baddi, Himachal Pradesh.

Key Responsibilities
  • Analyse software application user requirements and perform risk assessments following the CSA approach.
  • Develop test cases and scripts according to the risk category of each user requirement.
  • Execute test cases and gather relevant evidence for validation.
  • Document any deviations or issues identified during testing.
  • Prepare CSV lifecycle documentation, as needed.
  • Conduct all activities within the Polarion CSV tool in compliance with VMP/Procedures.
  • Ensure compliance with industry regulations, including 21 CFR Part 11, Annex 11, Data Integrity, and data security standards.
  • Collaborate with global and India-based teams, ensuring efficient communication and seamless project execution.
About You
  • A minimum of 5 years of experience in Computer System Validation (CSV), with a focus on GAMP Category 4 and 5 projects.
  • Demonstrated expertise in validating enterprise applications and performing risk-based assessments.
  • Strong knowledge of regulatory standards such as 21 CFR Part 11, Annex 11, and Data Integrity guidelines.
  • Excellent communication skills with the ability to work independently and within teams.
  • Flexibility to work onsite or remotely, depending on project requirements.
  • Familiarity with Polarion CSV tool or similar platforms is highly desirable.
  • Availability to travel.
  • Good knowledge of English.
What We Offer

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills, and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.



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