Position Title GxP Business Analyst – SDLC Documentation & Application Upgrade Support

Location: Pan India

Experience: 7+ years to 15 years

Interested folks can share resume on below mail ID-

[email protected]

Role Summary

We are seeking an experienced GxP Business Analyst to support regulated application upgrade initiatives within the Life Sciences/Pharmaceutical workplace. The resource will be responsible for preparing, reviewing, and maintaining SDLC and validation documentation required for GxP-compliant system upgrades. The role will work closely with business stakeholders, quality assurance, validation teams, project managers, and technical teams to ensure compliance with regulatory requirements and company quality standards.

Key Responsibilities

Business Analysis
- Gather and document business, functional, and regulatory requirements for GxP application upgrade projects.
- Conduct stakeholder interviews and workshops to understand current and future-state processes.
- Perform impact assessments and gap analyses related to application upgrades.




- Support risk assessments and change control activities.

SDLC Documentation
- Create, review, and maintain SDLC deliverables including:
- Business Requirements Specification (BRS)
- Functional Requirements Specification (FRS)
- User Requirements Specification (URS)
- Configuration Specification (CS)
- Traceability Matrix (RTM)
- Validation Plans and Summary Reports
- Change Requests and Change Impact Assessments
- SOP updates and associated documentation
- Ensure all project documentation adheres to organizational SDLC standards and GxP regulations.

Computer System Validation (CSV) Support
- Support validation lifecycle activities for application upgrades.
- Assist in preparation and review of validation documentation.
- Coordinate review and approval workflows with Quality Assurance teams.
- Ensure traceability between requirements, testing, and validation evidence.

Stakeholder Coordination
- Coll

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