Description
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, andquality management within Saama business lines to establish and ensure that Saama’s products andservices 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 perapplicable 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 appropriateValidation 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 toensure 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 compliancewith local and international regulations. Provide supervision and coaching to team members as needed. Liaise with functional representatives and product management, product owner, validation, andtesting staff to problem-solve directly or escalate issues. Ensure that development and business processes comply with internal standards, regulatoryrequirements, 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 andprocess 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 aregulated 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 & efficientlyWork 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 DutiesContributes 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 departmentMaintains 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 ofthe 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 andapplicants for employment and prohibits discrimination and harassment of any type withoutregard to race, color, religion, age, sex, national origin, disability status, genetics, protectedveteran status, sexual orientation, gender identity or expression, or any other characteristicprotected 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, andtraining.
