Job Description
Validation Specialist - ETQ Reliance / Quality Systems
Position Description
We are seeking an experienced Validation Specialist with deep expertise in ETQ Reliance, Quality Management Systems (QMS), Life Sciences regulations, and computer system validation. The ideal candidate will lead validation activities for quality systems while ensuring compliance with FDA, GxP, and industry standards. This individual will collaborate with Quality, IT, Business stakeholders, and vendors to support the implementation, enhancement, validation, and maintenance of ETQ Reliance and related quality applications utilizing both SDLC and Agile methodologies.
This role can be performed remotely.
Your future duties and responsibilities
. Lead validation efforts for ETQ Reliance implementations, upgrades, enhancements, and integrations.
. Develop and execute validation deliverables, including:
o Validation Plans
o User Requirements Specifications (URS)
o Functional Specifications (FS)
o Risk Assessments
o Installation Qualification (IQ)
o Operational Qualification (OQ)
o Performance Qualification (PQ)
o Traceability Matrices
o Validation Summary Reports
. Ensure compliance with FDA, GxP, 21 CFR Part 11, and applicable regulatory requirements.
. Partner with Quality, Manufacturing, and IT teams to define system requirements and validation strategies.
. Support configuration, workflow validation, testing, and release management activities within ETQ Reliance.
. Conduct risk-based validation assessments and recommend compliance strategies.
. Ensure computerized systems remain in a validated state throughout their lifecycle.
. Collaborate within Agile project teams, participating in sprint planning, backlog refinement, testing, and release activities.
. Support data migration validation and system integration testing activities.
Required qualifications to be successful in this role
. 5+ years of Computer System Validation (CSV) experience within Life Sciences, Pharmaceutical, Biotechnology, Medical Device, or regulated environments.
. 3+ years of hands on ETQ Reliance experience.
. Strong expertise in Quality Management Systems (QMS).
. Extensive knowledge of:
o FDA Regulations
o GxP Requirements
o 21 CFR Part 11
o Data Integrity Principles
o Computer System Validation Methodologies
. Experience developing validation deliverables from requirements through release.
. Experience supporting software development projects utilizing SDLC methodologies.
. Experience working in Agile and Scrum environments.
. Strong understanding of software testing methodologies, defect management, and release processes.
. Excellent technical writing, documentation, and communication skills.
. Ability to work independently and manage multiple priorities simultaneously.
Preferred Qualifications
. Experience validating cloud-based applications and SaaS platforms.
. Knowledge of GAMP 5 guidance and risk-based validation approaches.
. Experience with:
o CAPA Management
o Change Management
o Deviations
o Audit Management
o Document Control
o Training Management
o Supplier Quality
. Experience with regulated system integrations and data migration projects.
Required Technical Skills
. ETQ Reliance Configuration and Validation
. Computer System Validation (CSV)
. Quality Management Systems (QMS)
. FDA Compliance & Requirements
. SDLC Methodologies
. Agile/Scrum Frameworks
. Requirements Management
. Risk Assessments
. Test Script Development & Execution
. Defect Tracking and Resolution
. Audit Readiness and Compliance
Other Information:
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $89,600.00 $198,400.00.
CGI's benefits are offered to eligible professionals on their first day of employment to include:
. Competitive compensation
. Comprehensive insurance options
. Matching contributions through the 401(k) plan and the share purchase plan
. Paid time off for vacation, holidays, and sick time
. Paid parental leave
. Learning opportunities and tuition assistance
. Wellness and Well being programs
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Job Tags
Local area, Remote work