Validation Specialist – Quality Systems, ETQ Reliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee validation initiatives for ETQ Reliance implementations, upgrades, enhancements, and integrations.

• Create and implement validation plans, User Requirement Specifications (URS), functional specifications, risk assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), traceability matrices, and validation summary reports.

• Ensure adherence to FDA regulations, GxP standards, 21 CFR Part 11, and other relevant regulatory requirements.

• Collaborate with Quality, Manufacturing, and IT teams to establish system requirements and validation strategies.

• Assist in configuration, workflow validation, testing, and release management tasks within ETQ Reliance.

• Perform risk-based validation evaluations and propose compliance strategies.

• Maintain the validated status of computerized systems throughout their lifecycle.

• Engage with Agile project teams through sprint planning, backlog refinement, testing, and release activities.

• Aid in data migration validation and system integration testing efforts.

• Partner with Quality, IT, business stakeholders, and vendors for quality application implementation, enhancement, validation, and maintenance.

• Apply Software Development Life Cycle (SDLC) and Agile methodologies.

• Contribute to CGI's IT and business consulting services for clients.

⛳️ Requirements

• A minimum of 5 years of Computer System Validation (CSV) experience in Life Sciences, Pharmaceutical, Biotechnology, Medical Device, or regulated environments.

• At least 3 years of practical experience with ETQ Reliance.

• Proficient in Quality Management Systems (QMS).

• Deep understanding of FDA Regulations.

• Extensive knowledge of GxP Requirements.

• Well-versed in 21 CFR Part 11.

• Comprehensive knowledge of Data Integrity Principles.

• Thorough understanding of Computer System Validation Methodologies.

• Experience in developing validation deliverables from requirements to release.

• Background in supporting software development projects following SDLC methodologies.

• Familiarity with Agile and Scrum environments.

• Strong grasp of software testing methodologies, defect management, and release processes.

• Excellent skills in technical writing, documentation, and communication.

• Capable of working independently while managing multiple priorities simultaneously.

• Experience validating cloud-based applications and Software as a Service (SaaS) platforms.

• Knowledge of GAMP 5 guidance and risk-based validation methodologies.

• Experience with CAPA Management, Change Management, Deviations, Audit Management, Document Control, Training Management, and Supplier Quality.

• Experience in regulated system integrations and data migration projects.

• Proficient in ETQ Reliance Configuration and Validation.

• Knowledgeable in Computer System Validation (CSV) practices.

• Familiarity with Quality Management Systems (QMS).

• Understanding of FDA Compliance & Requirements.

• Knowledge of SDLC Methodologies.

• Proficient in Agile/Scrum Frameworks.

• Skills in Requirements Management.

• Experienced in Risk Assessments.

• Capable of Test Script Development & Execution.

• Knowledgeable in Defect Tracking and Resolution.

• Familiar with Audit Readiness and Compliance.

• Ability to successfully pass a background investigation.

• U.S. employment offers may be subject to credit checks based on assignment and security-clearance requirements.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive insurance benefits.

• Matching contributions via the 401(k) plan and share purchase plan.

• Paid time off for vacations, holidays, and sick leave.

• Paid parental leave.

• Opportunities for learning and tuition assistance.

• Wellness and wellbeing programs.

• Ownership opportunities from the first day of employment.

• Global capabilities along with industry and technology expertise.

• Career development and skill-building opportunities.

• Reasonable accommodations for qualified individuals with disabilities.