Key Responsibilities:

<ul>
<li>Perform functional, regression, and UAT testing for TrackWise applications.</li>
</ul>

<ul>
<li>Ensure compliance with GxP, FDA, and 21 CFR Part 11 requirements.</li>
</ul>

<ul>
<li>Prepare and execute validation deliverables including Test Plans, Test Cases, RTM, and Test Summary Reports.</li>
</ul>

<ul>
<li>Review and support CSV (Computer System Validation) documentation.</li>
</ul>

<ul>
<li>Work closely with business, quality, and development teams to understand requirements and ensure compliant testing.</li>
</ul>

<ul>
<li>Identify, document, and track defects using test management tools.</li>
</ul>

<ul>
<li>Support audits and inspections by providing required testing and validation evidence.</li>
</ul>

Required Skills &amp; Experience:

<ul>
<li>3–6 years of experience in testing TrackWise applications.</li>
</ul>

<ul>
<li>Strong understanding of GxP regulations, FDA guidelines, and 21 CFR Part 11.</li>
</ul>

<ul>
<li>Hands-on experience with Computer System Validation (CSV).</li>
</ul>

<ul>
<li>Experience in SDLC/STLC within regulated environments.</li>
</ul>

<ul>
<li>Knowledge of defect management and test management tools.</li>
</ul>

<ul>
<li>Good communication and documentation skills.</li>
</ul>

Preferred Skills:

<ul>
<li>Experience in Life Sciences / Pharma / Healthcare domains.</li>
</ul>

<ul>
<li>Exposure to Agile or Waterfall methodologies.</li>
</ul>

<ul>
<li>ISTQB or similar certification is a plus.</li>
</ul>

QA Engineer in Thoraipakkam (UID-14875)

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Job Description for QA Engineer

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