Raimundo Ilarraza Email & Phone Number

I’m a Quality oriented professional with a BS in Chemistry. Over 15 years experience in the pharmaceutical, medical devices, biotechnology and related life sciences industries.My main functions will be resume in:: Developed Part 11 Compliance Assessment Reports • Developed Data Integrity Assessment Reports • Validation of MES/EBR (Propack/Werum) • Develop, review and approve computer system validation protocols, QCL and Engineering GMP documentation • Develops and executes Periodic review of computerized systems and applications • In-house consulting on corporate policy and regulatory requirements for computer system validation • Document Controller • Prepare computerized systems documentation such as Validation Plan, CSV Risk Assessment, Test Plans, Test Summary Reports, Test Scripts, Traceability Matrix, Validation Summary Reports • Organized meetings with clients to meet their satisfaction • Prepared Annual Product Review reports • Statistical evaluation for Annual Product Review • Product recommendations after product evaluation • Design and maintain a Disaster Recovery plan and Business Continuity plan to all laboratory systems • Perform backup of all systems of the laboratory • Performing GAP Assessments of current procedures and operations against established Global Quality Standards and Common Quality Practices(GQS/CQP) • Revising and/or originating procedures in order to comply with Quality Plan, CAPA System requirements and operational needs • Re-qualification of Depyrogenation Tunnels, dryers and Autoclaves • IT project validation • Systems integration and custom development projects • Data Integrity Assessment • Part 11 Assessments • Water System Validation. Specialties: Computer system life cycle.GAMP 5; CFR 21 Part 11, 210, 211, 312, 314, 801, 803, 806, 810, 820, 821 and 860.

Listed skills include Gmp, Validation, Fda, Change Control, and 45 others.

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  Interamerican University

  Bs