Systems Validation Analyst – Junior

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SoftExpert - Software for Excellence

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Enterprise • SaaS • Compliance

SoftExpert is an integrated software suite designed to enhance performance excellence across various organizations. The platform offers comprehensive solutions including Business Process Management (BPM), Enterprise Resource Management (ERM), Environmental, Social, and Corporate Governance (ESG), and Quality Management systems, among others. SoftExpert empowers companies to automate processes, ensure compliance with regulatory standards, drive innovation, and improve overall operational efficiency through a user-friendly interface and modular architecture.

501 - 1000 employees

Founded 1995

🏢 Enterprise

☁️ SaaS

📋 Compliance

📋 Description

• Prepare, review and manage validation documents (URS, FS/CS, risk analyses, IQ, OQ and reports) • Execute tests and record evidence during validation projects • Help develop validation schedules with clients • Support implementation, migration, upgrade and regulatory compliance projects • Prepare materials and documentation for client audits and inspections • Participate in technical meetings and support clients with questions about standards and validation best practices • Contribute to the continuous improvement of templates and processes used by the area.

🎯 Requirements

• Bachelor's degree completed or in progress (Pharmacy, IT, Engineering, Production, Systems, Quality or related fields) • Knowledge or experience with Computerized Systems Validation (CSV) • Familiarity with GAMP 5, the validation lifecycle and data integrity • Document organization and technical writing skills • Microsoft Office • You will stand out if you have: • Previous experience validating systems in regulated environments • Knowledge of SoftExpert Suite • Experience with ERPs, LIMS, MES, WMS or automation systems • Participation in regulatory audits • Intermediate or advanced English and/or Spanish

🏖️ Benefits

• Unimed Health Plan: No monthly premium for the primary member and only 30% copayment • Annual Bonus: We recognize and reward your efforts with a special annual bonus • Meal Allowance or Food Voucher: Enjoy meals without payroll deductions, with a benefit of R$884.00 • Education Assistance: Scholarships for language courses, undergraduate, postgraduate or specialization studies, with monthly reimbursement up to 70% • TotalPass: Access to a nationwide network of gyms, psychologists and nutritionists with an exclusive discount • Dental Plan: Choose from three comprehensive plans to care for your smile across Brazil • 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 development programs • Pharmacy Partnership • Life Insurance