CSV (Validation) Business Analyst

Job Description:

DXC Technology (NYSE: DXC) helps global companies run their mission-critical systems and operations while modernizing IT optimizing data architectures and ensuring security and scalability across public private and hybrid clouds. The worlds largest companies and public sector organizations trust DXC to deploy services across the Enterprise Technology Stack to drive new performance levels competitiveness and customer experience. Learn more about how we deliver excellence for our customers and colleagues at .

CSV (Validation) Business Analyst

The CSV Business Analyst is responsible for eliciting analyzing and documenting business requirements for GxP-regulated computer systems. You will ensure that all functional and technical specifications are written with validation in mind facilitating the creation of testable requirements that meet both business goals and regulatory standards (21 CFR Part 11 Annex 11).

Requirements

1. Requirements Management

• Elicitation: Lead workshops with stakeholders to capture business needs.

• Documentation: Create high-quality User Requirements Specifications (URS) and Functional Specifications (FS) that are clear concise andmost importantlytestable.

• Traceability: Develop and maintain the Requirements Traceability Matrix (RTM) to ensure every business requirement is linked to a functional spec and a validation test script.

2. Validation Lifecycle Support

• Impact Assessment: Evaluate how proposed system changes affect the validated state of the system.

• Risk Assessment: Assist the CSV Lead in performing functional risk assessments (FMEA or similar) to determine the depth of testing required for specific features.

• Test Support: Review Validation Test Scripts (IQ/OQ/PQ) to ensure they actually prove the requirements work as intended from a business perspective.

3. Process & Compliance

• Data Integrity: Ensure requirements include necessary data integrity controls (audit trails electronic signatures archival).

• SOP Development: Draft or update Standard Operating Procedures (SOPs) and User Manuals for the newly validated systems.

• Change Control: Manage the technical change request process ensuring business justification is documented.

Key Responsibilities

• Validation Strategy: Develop and maintain the Validation Master Plan (VMP). Define the scope of validation efforts using a risk-based approach (GAMP 5).

• Lifecycle Documentation: Lead the creation review and approval of core validation deliverables including:

• User Requirements Specifications (URS)

• Risk Assessments (RA)

• Functional/Configuration Specifications

• Validation Plans & Summary Reports

• Testing Oversight: Manage the execution of IQ OQ and PQ (Installation Operational and Performance Qualification). Ensure deviations are documented investigated and closed correctly.

• Data Integrity: Act as the subject matter expert (SME) for ALCOA principles ensuring systems are designed to maintain electronic record integrity.

• Audit & Inspection Support: Represent the CSV function during internal audits and external regulatory inspections (e.g. FDA EMA). Defend validation packages to auditors.

• Vendor Management: Perform technical audits of software vendors and SaaS providers to ensure their SDLC processes meet GxP requirements.

• Change Control: Review and approve system changes to ensure the validated status is maintained throughout the systems life.

Basic Qualifications

• Bachelors degree in Business IT Science or a related field.

• Certifications like CBAP (Certified Business Analysis Professional) or training in GAMP 5 are highly desirable.

Physical Requirements / Work Environment

• Project location Budapest - Hybrid

• Ability to participate in virtual meetings across multiple time zones.

#LI-hybrid

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