Job Summary :

Job Title : Principal, GxP Validation & QA Engineer

Experience : 8+ Years

Location : Bangalore( Hybrid 3 days office in a week )

Fulltime Employment.

Role & responsibilities

- 8+ years of experience in computer system validation, software quality assurance, or GxP compliance within a regulated medical device, pharmaceutical, or life sciences workplace.
- Demonstrated expertise applying GAMP 5, 21 CFR Part 11, EU Annex 11, 21 CFR Part 820, ISO 13485, and EU MDR to enterprise technology systems.
- Proven experience authoring and executing full validation of lifecycle documentation (validation plans, risk assessments, requirements traceability, IQ/OQ/PQ, summary reports).
- Hands-on experience validating enterprise platforms such as ERP (SAP), PLM, MES, LIMS, QMS, or data and integration platforms.
- Working knowledge of data integrity requirements and ALCOA+ principles.
- Experience with test management and ALM tools (e.g., Jira, Azure DevOps, HP ALM/Micro Focus ALM, Veeva, TrackWise).




- Experience delivering within Agile product teams and applying Computer Software Assurance (CSA) or risk-based testing approaches.
- Strong analytical, problem-solving, and technical writing skills, with the ability to influence cross-functional stakeholders.
- Demonstrated ability to lead complex initiatives and mentor junior engineers without direct people management authority.
- Proven knowledge in validation for regulated environments (GxP, CSA, CSV)

Preferred candidate profile

- Experience supporting regulatory inspections or audits (FDA, Notified Body, or equivalent).
- Experience validating cloud/SaaS solutions and applying supplier qualification approaches for externally hosted GxP systems.
- Experience with test automation frameworks and CI/CD pipelines in a validated environment.
- Experience validating AI/ML, analytics, or advanced automation solutions in a GxP context.
- Prior experience supporting a company separation, carve-out, or large-scale ERP/system migration.

📌 Principal, GxP Validation & QA Engineer (Bengaluru)
🏢 Vision Data Analytics
📍 Bengaluru