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Strong pharma brand and Hyderabad metro location but niche CSV specialization limits applicant pool.
Pharma GxP and CSV expertise is highly industry-specific, limiting cross-industry transferability.
Explicit 7-9 years requirement plus mandatory GxP/CSV compliance makes filters highly stringent.
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Lead and participate in Computer System Validation (CSV) activities across multiple GxP business areas to ensure applications are fit for production release.
Conduct risk and impact assessments to determine validation and qualification requirements for applications and infrastructure.
Support inspections, audits, periodic compliance reviews, and author CSV deliverables including plans and summary reports.
Bachelor's degree (B.E./B.Tech.) in computer science, engineering, or life sciences.
7-9 years experience in computer systems validation in the pharmaceutical industry, including at least 3 years managing CSV projects.
Mandatory knowledge of IT testing practices and methodologies in Pharma GxP and test management tools like ALM.
Must have working knowledge of Electronic Records and Electronic Signature regulations, Data Integrity principles, and GAMP methodology.
Experienced in validating GxP systems such as CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, or Regulatory Submission systems.
Able to work independently with minimal supervision and make decisions impacting own work and other teams.
Comfortable working within established procedures and supporting audit and remediation activities in a regulated pharmaceutical environment.