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SoftExpert - Software for Excellence logo
SoftExpert - Software for Excellence

Software all-in-one para gestão da transformação digital, inovação e conformidade.

Systems and Processes QA Assistant

QA EngineerQA EngineerFull TimeRemoteSeniorTeam 501-1,000Since 1995H1B No SponsorCompany SiteLinkedIn

Location

Brazil

Posted

74 days ago

Salary

0

Seniority

Senior

Bachelor DegreePortuguese

Job Description

Systems and Processes QA Assistant

SoftExpert - Software for Excellence

• 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

Job Requirements

  • 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

Benefits

  • 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

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