Functional Testing Specialist

4 days ago

Vadodara, Gujarat, India beBeeValidation Full time US$ 90,000 - US$ 1,20,000

Job Summary:

We are seeking a highly skilled Functional Testing Specialist with extensive experience in pharmaceutical quality systems, including Trackwise, Labware LIMS, and Documentum D2. The ideal candidate will have a strong background in validation, configuration, and compliance-driven testing in a regulated environment.

Main Responsibilities:

  • Lead validation and configuration efforts for Trackwise, Labware LIMS, and Documentum D2 platforms.
  • Develop and execute test strategies, protocols, and test scripts to ensure GxP, 21 CFR Part 11, and overall regulatory compliance.
  • Conduct impact assessments, lead UAT support, and defect triage to guarantee accurate system validation.
  • Review SOPs, system documentation, and create traceability matrices to maintain system integrity.

Key Qualifications:

  • 5+ years of experience in QA/QC systems in the life sciences/pharmaceutical domain.
  • Proficiency in Trackwise, Labware LIMS, and Documentum D2 platforms.
  • Strong experience in validation lifecycle documentation (IQ, OQ, PQ).
  • Solid understanding of GAMP 5, FDA 21 CFR Part 11, and CSV best practices.
  • Excellent communication and documentation skills.
  • Experience working with global cross-functional teams is a plus.

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