Validation Specialist
Job Summary
Job Description
The Validation Specialist (Quality Validation Analyst - QVA 1) is responsible for defining and executing validation test strategies, driving continuous improvement in quality assurance, and ensuring products meet quality standards. This role collaborates with product management, development, and quality management to validate Saama's products and services throughout their lifecycle and in compliance with applicable regulations. Key responsibilities include product testing, implementation, documentation, and ensuring adherence to regulations such as FDA, GDPR, and ICH guidelines. The role involves participating in risk management, executing test cases, and reviewing lifecycle deliverables and documentation to ensure quality standards are met and maintaining an audit-ready state. Additionally, the specialist supports process improvements, troubleshooting, and provides guidance to team members.
Must have:
- Define and execute validation test strategy
- Ensure compliance with regulations (FDA, GDPR, ICH)
- Execute validation test cases
- Participate in Risk Management
- Review lifecycle deliverables and documentation
- Maintain audit-ready validation documentation
- Support process validation
- Good troubleshooting and communication skills
- Team-oriented with excellent communication and organizational skills
- Strong interpersonal and communication skills, both verbal and written
Good to have:
- Experience with Design Controls (Computer System Validation)
- Experience with Quality Management systems (21 CFR Part 820, ISO 9001, ISO 13485)
- Experience in cGMP and/or GCP-regulated environments
- Experience with risk-based validation
- Knowledge of GAMP5 and CSA guidelines
- Experience in Audits and Inspections
- Additional language skills
6 skills required
Job Details
QVA 1
Saama Technologies, LLC
Position Overview:
This position is responsible for defining and executing the validation test strategy, driving continuous
improvement for quality assurance-related activities, and ensuring products meet quality standards.
The Quality Validation Analyst (QVA) 1 works closely with product management, development, and
quality management within Saama business lines to establish and ensure that Saama’s products and
services are validated under the established product lifecycle and applicable regulations.
The QVA 1 is responsible for product testing, product implementation, and documentation tasks.
Key relationships:
● Information Technology
● Product Management
● Research & Development
● Quality management organization
● Business Teams
● Operations
What We Value
● Integrity: doing the right thing
● Solutions: solving core, complex business challenges
● Collaboration: working as one team
● Innovation: changing the game
● Transparency: communicating openly
● Enjoy & Celebrate: having fun
Key Responsibilities:
Ensures compliance with regulations (e.g., FDA, GDPR) and ICH guidelines regarding product
development, testing, and implementation.
Ensure that internal Verification & Validation testing of designated products is completed per
applicable procedures and industry standards.
Collaborates on authoring test cases based on the defined intended use
Participates in Risk Management throughout the product life cycle, incl. production and post-
release.
Executes validation test cases to ensure satisfactory completion and schedule alignment.
Determine if the test case prerequisites (e.g., test data and user account credentials provisioned)
for validation testing are fulfilled.
Determine the scope of retesting required following defect fixes or risk identified.
Ensures that product deployments/implementation projects are validated per appropriate
Validation Plans.
Review lifecycle deliverables agreed upon for the project to ensure they are authored, approved,
and executed to meet quality standards.
Review lifecycle documentation related to products; consider current standards and regulations to
ensure that outputs have been completed before becoming a final product.
Maintain the validation deliverable package in an audit-ready state
Supports revision of applicable procedures, policies, and work instructions to ensure compliance
with local and international regulations.
Provide supervision and coaching to team members as needed.
Liaise with functional representatives and product management, product owner, validation, and
testing staff to problem-solve directly or escalate issues.
Ensure that development and business processes comply with internal standards, regulatory
requirements, and industry best practices by participating in and facilitating process validations.
Conduct quality assessments and validation of third parties
Participate in audits and inspections as required, providing applicable validation documents and
process overviews
Education:
Technical Education (Bachelor's degree or equivalent) in computer sciences, health/life sciences,
or equivalent is required, as is relevant work experience in a product development environment.
Experience:
Preferred at minimum 2 years of experience with Design Controls (e.g., Computer System
Validation) and Quality Management systems (21 CFR Part 820, ISO 9001, ISO 13485) in a
regulated environment.
Preferred at least 1 years working in cGMP and/or GCP-regulated environments.
Experience with risk-based validation
Knowledge of and ability to apply GAMP5 and CSA guidelines
Good troubleshooting and communication skills
Experience in Audits and Inspections is preferred
Good command of English. Additional language skills are preferred.
Experience participating in the CAPA resolution process.
Excellent skills in analyzing issues and processes.
Team-oriented with excellent communication and organizational skills.
Strong interpersonal and communication skills, both verbal and written
Goal oriented
Detail oriented
Ability to make sound judgments
Superior problem-solving skills
Ability to manage multiple tasks effectively & efficiently
Work Environment
● Remote
● Travel less than 20% to an office environment
Physical Demands
● This position requires frequent and repetitive use of a computer, keyboard, and mouse, as well as
hand and finger dexterity.
Other Duties
Contributes to team effort by
Exploring new opportunities to add value to organization and departmental processes.
Leveraging technical knowledge to troubleshoot issues
Communicating risks, defects, and quality issues to ensure process transparency
Identifying potential risks related to quality/testing and developing mitigations
Maintain the status of documents in design projects.
Establishing knowledge of all core lifecycle processes
Contributes to the establishment and tracking of KPIs and Metrics for the department
Maintains Professional and Technical Knowledge by
Attending and participating in applicable company-sponsored training
Attending educational workshops and reviewing professional publications
Benchmarking state-of-the-art practices
Participating in professional societies
Keeping informed of changes in the regulatory environment and/or regulatory requirements
Please note that this job description is not designed to cover or contain a comprehensive listing of
the activities, duties, or responsibilities that are required of the employee for this job. Duties,
responsibilities, and activities may change at any time, with or without notice.
EEO
Saama Technologies, LLC. provides equal employment opportunities to all employees and
applicants for employment and prohibits discrimination and harassment of any type without
regard to race, color, religion, age, sex, national origin, disability status, genetics, protected
veteran status, sexual orientation, gender identity or expression, or any other characteristic
protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring,
placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and
training.
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