Agustina Jansen

Background

About Agustina Jansen

Thorough understanding of testing application development and validation for various applications such as MES/PASX – Werum; Tulip MES, TrackWise, Veeva, MasterControl, L7 LIMS, CMMS, Maximo, Empower, etc.• Goal oriented professional with over 22 years of pharma experience. • GLP, GCP- and GMP-regulated environments. • Over 20 years experience as project lead on large and small validation projects and authoring and/or executing testing, authoring summary reports and other validation deliverables such as validation plans, FMEA risk assessments, GxP/Part 11 risk assessments Validation Plans, Impact Assessments, requirements documents and Traceability Matrices, Validation Summary Reports, Test Plans, Test Protocols/Test Cases. • Develop and maintain quality systems based upon Lean 6 Sigma principles and in accordance with FDA regulations, industry standards (GAMP), and internal policies and procedures.• Strong knowledge of 21 CFR Part 11 and predicate rule requirements (21 CFR Parts 210 and 211; 21 CFR Part 820; and 21 CFR Part 312. • Developed and implemented 21 CFR Part 11 Compliance Assessment Policy that included training, SOPs and work instruction to ensure compliance with e-record maintenance requirements.• Maintain productive business relationships and team environment with system owners / users, IT (software development test engineers, IT infrastructure/IT maintenance), and other support team members. • Audit software vendors for new systems and perform required audits of vendors according to QA policies and procedures and SDLC software maintenance requirements. Audited CROs’ for SDLC policies and procedures, quality systems, and critical system validation, and validation and maintenance documentation to be used during clinical trials to ensure compliance with CRO policies and procedures and FDA regulations.• Serve as Validation department representative during FDA audits to provide evidence of Quality Systems / SDLC compliance.Specialties: Data Integrity Risk assessment, FMEA, software quality life cycle management; Vendor and CRO auditing; Risk-based approach to Validation; Authoring Validation Planning/Summary Report Protocols/Reports, requirements and traceability; Performing testing in controlled environments; Six Sigma/Lean Management techniques; Configuration Management, Change Control, and Impact Assessment