**Role & seniority: ** Experienced CSV/CSA Consultant (≈6+ years), supporting GxP-regulated validation/compliance in Life Sciences.

**Stack/tools: **

Methods/standards: GAMP 5, CSA, CSV, risk-based validation
Regulatory/data integrity: FDA 21 CFR Part 11, EU Annex 11, ALCOA+
Test/traceability & validation docs: URS/FS/DS, TM, test scripts, TSR, validation reports
Cloud/IT validation scope: SaaS, PaaS, IaaS, hybrid; IQ/OQ for databases/storage/load balancers/network, virtualized environments
Tools (preferred): ValGenesis, Jira, qTest, ServiceNow, Veeva, TrackWise, ComplianceWire
PV/LMS systems (preferred): Argus, ArisG, SafetyEasy, PV Works; LMS/eLearning/content platforms
Top 3 responsibilities:
- Lead/execute CSV & CSA for GxP systems; define validation strategy, testing approach, deliverables, and traceability.
- Perform risk assessments (SRA/FRA) and apply CSA to focus validation on critical functions affecting patient safety, product quality, data integrity.
- Support IT/GxP compliance: change control, deviations, CAPA, audit/inspection readiness, and integration into Agile/Waterfall/hybrid SDLC.
Must-have skills:
- Strong CSV/CSA execution in GxP Life Sciences environments
- Knowledge of 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+)
- Ability to validate across traditional + cloud/SaaS, including IQ/OQ
- **Risk

Full Description

Job Summary We are seeking an experienced CSV/CSA Consultant to support validation and compliance activities for GxP-regulated systems within a Life Sciences environment. The candidate will be responsible for applying GAMP 5, Computer Software Assurance (CSA), and risk-based validation methodologies across traditional, cloud, SaaS, Agile, and AI/ML-enabled platforms. The role requires expertise in Computer System Validation, Data Integrity, IT Compliance, Pharmacovigilance systems, and Quality Risk Management.

Key Responsibilities

Validation & Compliance Lead and execute Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems. Define validation strategy, testing approach, risk assessments, and validation deliverables following GAMP 5 and CSA principles. Develop and review Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Traceability Matrix (TM), Test Scripts, Test Summary Reports (TSR), and Validation Reports. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GxP, and Data Integrity requirements. Risk-Based Validation Conduct System Risk Assessments (SRA) and Functional Risk Assessments (FRA). Apply CSA methodologies to focus testing on critical system functions impacting patient safety, product quality, and data integrity. Leverage supplier documentation and vendor testing evidence based on risk evaluations and supplier assessments. Quality & IT Compliance Support change control, deviations, CAPA investigations, audit readiness, regulatory inspections, and quality governance activities. Participate in IT Quality Management and Quality Risk Management programs. Ensure validation deliverables meet internal SOPs and global regulatory expectations. Agile & Digital Platforms Support Agile, Waterfall, and Hybrid SDLC methodologies. Integrate validation activities with Sprint planning, user stories, release management, and product increments. Collaborate with Product Owners, Business Analysts, QA teams, and Technology teams. Cloud & Infrastructure Validation

Support qualification and validation of

SaaS Platforms
Cloud Applications
Infrastructure Components
Virtualized Environments
Databases
Storage Systems
Load Balancers
Network Components
Assess IaaS, PaaS, SaaS, and Hybrid Cloud architectures.
Data Integrity & AI/ML Compliance

Evaluate data integrity controls including

Audit Trails
User Access Management
Electronic Records & Signatures
ALCOA+ Principles
Data Lineage
Interfaces & Integrations
Support validation of AI/ML-enabled systems considering model explainability, data quality, drift monitoring, human oversight, and periodic reviews.
Pharmacovigilance Support
Support validation activities for Pharmacovigilance systems and safety platforms.
Understand safety workflows, regulatory reporting requirements, and validation documentation associated with PV applications.
Learning Management Systems

Support validation and operational activities for

LMS Platforms
eLearning Applications
Content Management Systems
Develop training documentation and support training content authoring.

Required Qualifications

Education Bachelor's Degree in Computer Science, Information Technology, Life Sciences, Engineering, Pharmacy, or related field.

Experience 6+ years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), or Quality Compliance roles. Strong experience in GxP-regulated Life Sciences environments. Experience supporting Pharmacovigilance, Clinical, Quality, Manufacturing, or Regulatory systems.

Technical Skills

GAMP 5 Computer Software Assurance (CSA) Computer System Validation (CSV) FDA 21 CFR Part 11 EU Annex 11 Data Integrity & ALCOA+ Risk Assessment Validation Lifecycle Management Agile SDLC & Waterfall SDLC Change Control & CAPA Audit & Inspection Readiness Cloud Validation Infrastructure Qualification (IQ) Operational Qualification (OQ)

Preferred Qualifications

Experience with

ValGenesis
Jira
qTest
ServiceNow
Veeva
TrackWise
ComplianceWire
LMS Platforms

Knowledge of Pharmacovigilance systems such as

Argus
ArisG
SafetyEasy
PV Works
Experience validating AI/ML-enabled platforms.