Industry Consulting Manager
NTT DATA BUSINESS SOLUTIONS · Bengaluru · onsite · Posted 51d ago
Undisclosed8–13 yrsfulltimeSourced from
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About this role
We are currently seeking an Industry Consulting Manager to join our team in Bangalore, Karntaka (IN-KA), India.
Job Summary We are looking for an experienced GxP Validation Test Engineer to support testing and validation activities within a regulated life sciences environment. The role will be responsible for preparing compliant testing documentation, executing IQ, OQ, and PQ activities, managing defects, and maintaining audit-ready evidence under the direction and priorities of the Client.
Core Responsibilities - Prepare and maintain test plans, test scripts, protocols, evidence, and test summary reports.
- Execute GxP validation testing activities, including Installation Qualification, Operational Qualification, and Performance Qualification.
- Manage the complete testing lifecycle, including preparation, execution, defect management, reporting, and closure.
- Establish and maintain traceability between business requirements and test cases through the Requirements Traceability Matrix.
- Record, track, triage, and coordinate the resolution of defects with business and technical stakeholders.
- Ensure testing documentation complies with Client quality standards, procedures, and regulatory requirements.
- Maintain accurate, complete, and inspection-ready validation documentation.
- Provide regular testing status reports, defect trends, risks, and quality metrics to the Client.
- Support audit, inspection, and validation-readiness activities.
- Work within the agreed staffing plan, allocated capacity, and Client-defined priorities.
- 58 years of experience in software testing, computer system validation, or quality assurance within a regulated environment.
- Strong understanding of GxP, GMP, validation principles, and regulated testing practices.
- Hands-on experience executing IQ, OQ, and PQ protocols.
- Experience creating test plans, scripts, validation reports, and traceability matrices.
- Strong knowledge of defect management, test evidence, and validation documentation controls.
- Familiarity with regulatory expectations such as FDA 21 CFR Part 11, EU Annex 11, and data integrity principles.
- Experience using test management and defect-tracking tools such as ALM, Jira, Azure DevOps, or similar platforms.
- Strong analytical, documentation, communication, and stakeholder-management skills.
- Experience in pharmaceutical, biotechnology, medical device, or life sciences organisations.
- Knowledge of Computer System Validation and risk-based validation methodologies.
- ISTQB, quality, validation, or GxP-related certification is preferred.
Sourced from naukri
Skills
Test CasesAlmDevopsAzure DevopsCfrBusiness RequirementsistqbDefect managementClient SuccessBankingSystem ValidationBiotechnologysoftware testingJira AtlassiancloudQuality AssuranceMicrosoft AzurePharmaceuticalLife SciencesArtificial Intelligence
About NTT DATA Business Solutions
NTT DATA BUSINESS SOLUTIONS
IT Services & Consulting
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1989
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India
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NTT DATA Business Solutions helps clients innovate and transform through expert SAP solutions, advisory, implementation, and managed services.
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