Validation Tester Specialist

3 days ago

Pune, Maharashtra, India beBeeValidation Full time ₹ 9,00,000 - ₹ 12,00,000

Job Role:

Validation Testing Professional

We are seeking a highly skilled Validation Testing Professional to contribute to the development and implementation of Computer System Validation (CSV) activities. The ideal candidate will have over 3-5 years of experience in designing, executing, and documenting validation testing processes across multiple systems and platforms.

The successful candidate will be responsible for developing, executing, and maintaining test scenarios, test cases, and validation scripts in alignment with project requirements. They will also select appropriate testing methodologies, techniques, and evaluation criteria to ensure thorough system validation.

  • Develop comprehensive test plans and test cases to ensure high-quality system validation.
  • Collaborate with QA, development, and business teams to ensure test coverage and traceability.
  • Ensure compliance with regulatory standards such as 21 CFR Part 11, EU Annex 11, and GxP requirements.

Key responsibilities include:

Deliverables:
  • User Requirements Specifications (URS)
  • Functional Specifications (FS)
  • Design Specifications (DS)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Traceability Matrices
  • Configuration Documentation
  • Error Logs
  • Validation Summary Reports

Required qualifications include:

  • Strong understanding of computer system validation principles and practices.
  • Excellent technical writing and communication skills.
  • Ability to work collaboratively in a team environment.

Benefits of this role include:

  • Opportunity to work on high-profile projects.
  • Chance to develop and implement new technologies.
  • Competitive compensation package.

Join our dynamic team and contribute to the success of our organization.

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