CirrusLabs
Website:
cirruslabs.io
Job details:
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.
Click on Apply to know more.
