Qualifications &

Skills

- Bachelor's or Master's degree in Computer Science, Life Sciences, Engineering, Pharmacy, or related field.

- 3–8+ years of experience in Computer System Validation within GxP-regulated industries (pharma, biotech, medical devices).

- Solid knowledge of GAMP 5 guidelines, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity principles.

- Experience validating Laboratory systems (e.g., LIMS, CDS, ELN), Manufacturing systems (e.g., MES, SCADA, PLCs), ERP (SAP), or Cloud-based systems.

- Hands-on experience with risk-based validation approaches.

- Excellent documentation, analytical, and communication skills.

- Understands validation needs for AI/ML-enabled systems, including intended use, data quality, explainability, drift monitoring, human oversight, and revalidation triggers.

- Understanding of PV processes, system workflows, regulatory expectations,



documentation and support for validation lifecycle activities

Preferred (Nice to Have)

- Experience with cloud/SaaS validation (AWS, Azure, Veeva, etc.).

- Experience with Testing Tools like Jeera, qTest and ALM

- Knowledge of Agile / SDLC methodologies and their application in CSV.

- Prior involvement in regulatory inspections and client audits.

- Familiarity with 21 CFR Part 820 (Medical Devices) and ISO standards (ISO 13485, ISO 14971).

Additionally, eLearning Platform Support: Hands-on experience with eLearning platforms; Understanding of typical patterns and challenges in building and sustaining these platforms from a project management perspective

📌 CSV-GXP with AI ML - Deloitte (Telangana)
🏢 and let's build it together
📍 Telangana