Support maintaining the validated state of systems by assessing the impact of changes, fixes and enhancements
Contribute to the analysis of patches, adjustments and controlled changes, identifying technical, functional and process impacts
Assist in responding to customer inquiries about system behavior, features and possible deviations
Monitor and support the handling of incidents, deviations, non-conformities and service requests
Support tracking of corrective, preventive and evolutionary requests
Contribute to system qualification and requalification activities
Support initial requirements gathering, process understanding and solution design
Assist in defining and reviewing system parameterizations, access rights and system functions
Support the preparation, review and organization of technical and functional documents, such as:
Functional, technical and configuration specifications
Architecture documents
Risk analyses
Test protocols, scripts and reports
Support test execution, organization of evidence and consolidation of results
Ensure traceability between requirements, risks, tests, accesses and incidents
Collaborate with internal teams and clients, contributing to the quality of deliverables
Support continuous improvement of processes, controls and area templates

Previous experience analyzing changes, fixes, incidents or service requests in corporate systems
Ability to assess functional, technical and process impacts
Experience providing support to clients or internal departments
Familiarity with requirements gathering, system parameterization and access management
Experience with technical and functional documentation
Strong written communication, organization and attention to detail
Ability to work collaboratively and manage multiple demands
Knowledge of Computerized System Validation (CSV) (advantage)
Familiarity with standards and guidance such as GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and ALCOA++ (advantage)
Experience in regulated environments (advantage)
Knowledge of the SoftExpert Suite (advantage)
Experience with corporate systems (workflow, DMS/GED, quality) (advantage)
Experience in regulated industries (pharmaceuticals, chemical, food, healthcare, etc.) (advantage)
Intermediate or advanced English and/or Spanish (advantage)
Bachelor’s degree completed or in progress in areas such as IT, Engineering, Quality, Pharmacy, Chemistry or related fields

Unimed Health Plan: No monthly fee for the primary subscriber and only 30% co-pay
Annual Profit-Sharing (PLR): We recognize and reward your work with a special annual PLR
Meal or Food Allowance: Enjoy meals without payroll deductions, with a benefit of R$950.00
Education Assistance: Scholarships for language courses, undergraduate, graduate or specialization studies, with monthly reimbursement of up to 70%
TotalPass: Access to a network of gyms, psychologists and nutritionists across Brazil with an exclusive discount
Dental Plan: SulAmérica
Referral Bonus: Refer a friend and receive rewards in your Flash
Free Online Courses: Improve your skills with 100% free courses developed by SoftExpert
Internal and External Training: We invest in your growth with training programs
Pharmacy Discount Program
Life Insurance

Systems and Processes QA Assistant

Key skills