Computer System Validation Engineer
3 weeks ago
We are seeking a highly skilled Senior CSV Expert to join our team at PQE Group. As a key member of our team, you will be responsible for ensuring the validation of our computer systems meets the highest standards of regulatory compliance.
Key Responsibilities- Analyzing software application user requirements and performing risk assessments following the CSA approach
- Developing test cases and scripts according to the risk category of each user requirement
- Executing test cases and gathering relevant evidence for validation
- Documenting any deviations or issues identified during testing
- Preparing CSV lifecycle documentation, as needed
- Conducting all activities within the Polarion CSV tool in compliance with VMP/Procedures
- Ensuring compliance with industry regulations, including 21 CFR Part 11, Annex 11, Data Integrity, and data security standards
- Collaborating with global and India-based teams, ensuring efficient communication and seamless project execution
- 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
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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