Functional Testing Specialist

1 day ago

Amrāvati, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000
Job Description

We are seeking a highly skilled Functional Testing Lead to join our team. The ideal candidate will have hands-on experience in pharmaceutical quality systems, including Trackwise, Labware LIMS, and Documentum D2.

As a Functional Testing Lead, you will be responsible for leading validation and configuration efforts for Trackwise, Labware LIMS, and Documentum D2 platforms. This includes developing and executing test strategies, protocols, and test scripts, as well as ensuring GxP, 21 CFR Part 11, and overall regulatory compliance.

You will also be responsible for conducting impact assessments, leading UAT support and defect triage, reviewing SOPs and system documentation, and creating traceability matrices. Collaboration with QA/CSV/business teams is essential to ensure accurate system validation.

Required Skills and 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
Benefits

This role offers a unique opportunity to work with a talented team of professionals and contribute to the development of high-quality systems in life sciences. If you are a motivated and detail-oriented individual with a passion for functional testing, we encourage you to apply.

Others

Please note that this job description may be subject to change based on business needs.

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