GxP Business Analyst

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-

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Role Summary

We are seeking an experienced GxP Business Analyst to support regulated application upgrade initiatives within the Life Sciences/Pharmaceutical environment. 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

• Collaborate with project managers, application owners, QA, validation, and technical teams.
• Facilitate document review sessions and collect stakeholder feedback.
• Track action items, documentation approvals, and project deliverables.

Compliance & Quality

• Ensure compliance with:
• GxP regulations
• FDA 21 CFR Part 11
• GAMP 5 guidelines
• Data Integrity requirements (ALCOA+ principles)
• Internal Quality Management System procedures
• Support audit readiness and regulatory inspection activities.

Required Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, or related field.
• 7+ years of experience as a Business Analyst in GxP-regulated environments.
• Experience supporting pharmaceutical, biotechnology, medical device, or life sciences organizations.
• Strong understanding of SDLC methodologies and documentation standards.
• Experience with Computer System Validation (CSV) deliverables.
• Knowledge of FDA, GxP, GAMP 5, and 21 CFR Part 11 requirements.
• Strong analytical, documentation, and communication skills.
• Experience with document management systems and quality processes.

Preferred Qualifications

• Experience supporting application upgrade and migration projects.
• Knowledge of Agile and Waterfall methodologies.
• Experience with Quality Management Systems (QMS), LIMS, MES, ERP, Manufacturing, Clinical, or Regulatory applications.
• Certification in Business Analysis (CBAP, CCBA) or relevant validation certifications is a plus.

Key Skills

• Business Requirements Gathering
• SDLC Documentation
• GxP Compliance
• Computer System Validation (CSV)
• Requirements Traceability
• Change Control Management
• Risk Assessment
• Gap Analysis
• Stakeholder Management
• Document Review & Approval Coordination
• FDA 21 CFR Part 11
• GAMP 5

Deliverables

• Complete and approved SDLC documentation package.
• Requirements Traceability Matrix (RTM).
• Validation and compliance documentation supporting application upgrade projects.
• Change impact assessments and risk assessments.
• Audit-ready documentation repository.