Principal, GxP Validation & QA Engineer

Vision Data Analytics; Bengaluru; Híbrido; INR 2 500 000 - 7 000 000; Tempo integral

Resumo da oferta

Vision Data Analytics is seeking a Principal, GxP Validation & QA Engineer in Bangalore (Hybrid 3 days in office). The role requires 8+ years of experience in computer system validation, software QA, or GxP compliance within regulated environments.

The candidate will apply GAMP 5, CFR 21 Part 11, EU Annex 11, ISO 13485, and EU MDR to enterprise systems and lead validation across ERP/SAP, PLM, MES, LIMS, and QMS platforms.

Qualificações

• 8+ years in computer system validation, software quality assurance, or GxP compliance.
• Experience applying GAMP 5, 21 CFR Part 11, EU Annex 11, 21 CFR Part 820, ISO 13485, EU MDR to enterprise systems.
• Experience validating ERP/SAP, PLM, MES, LIMS, QMS or data/integration platforms.
• Familiarity with data integrity requirements and ALCOA+ principles.

Responsabilidades

• Validate lifecycle documentation: validation plans, risk assessments, requirements traceability, IQ/OQ/PQ, summary reports.
• Lead validation for enterprise platforms and data/integration systems.
• Apply CSA and risk-based testing within Agile product teams.
• Mentor junior engineers and influence cross-functional stakeholders.

Conhecimentos

GxP validation

Quality assurance

Regulatory compliance

GAMP5

CSA/CSV

ALCOA+

Agile

Risk-based testing

Cross-functional mentoring

Ferramentas

Jira

Azure DevOps

HP ALM

Micro Focus ALM

Veeva TrackWise

Descrição da oferta de emprego

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 environment.
• 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.