Gunter Barbosa-Friedrich

-Revision of Computer System Validations (SCADA, DCS- P (WinCC and PCS 7) according to consistency, correctness, and completeness with the focus on data integrity. -Validation of Computerized Systems (NTP Server, Temp. Recording Systems, etc.) -Contribution to the development of the Content Management System (Maximo) -Creation of the URS for a Backup Solution -Authoring of validation documents -Test performance -Provision of trainings to the project team

Validation Lead of an Agile MES Project -Support of the project-team regarding GxP-relevant questions. -Creation of validation documentation. -Providing trainings to the project-team according to GAMP 5 and related supplements -Lead of the test team -Development of validation strategy.

-Validation of an application for electronic signatures -Creation of contractual documents like SLA -Provision of trainings regarding validation aspects following GAMP 5.

-Development of SOPs for Software Development Life Cycle (SDLC) -Development and improvement of SDLC -Authoring of OLA (Operational Level Agreement) regarding Incident Management and Problem Management.

-Development of SOPs for Software Development Life Cycle (SDLC) -Development and improvement of SDLC

-Computer System Validation and Project Lead from validation perspective of a Packaging System (cloud system). Covering all validation aspects except IQ, which has been done by the supplier. -Supporting supplier regarding QMS development and GMP aspects. -Validation of a Serialisation System with a high degree of automation

Team Lead of an qualification stream of gluing processes. Identifying and qualifying all gluing processes of the company. Bracketing of similar processes and identifying worst case parameters. Identifiying processes which math with the worst case parameters and defining test methods for testing intermediate products.

Validation Lead: Validation of an MES System (Simatic IT). The MES system was extended by an additional highly customized module, which had to be validated.

Computer System Validation Validation lead of a validation project of a Clean Room Monitoring and Labelling System.

-Computer System Validation Lead of a computer system validation related project for a recipe test system for the production biochemical products (MES).

Equipment Qualification of medical devices in the course of a remediation project.

-Quality Assurance/eCompliance for a globally used application during operational and developing phase. -Quality Assurance/eCompliance for a globally used Track & Trace project which was initially implemented and in-house developed.

Computer System Validation CSV-Remediation Project: authoring of validation documentation for various automated equipment like laser markers and cleaning devices following the path of the V-Model. -Equipment qualification (Qualification of laser markers, zone furnace, climatic exposure test cabinet, etc.) o Authoring of entire validation documentation (Plans, Reports, Test Specifications, Risk Analyses).

Change Management, CAPA, Configuration Management, Computer System Validation, Equipment Qualification Project Lead of Automation Qualification project (construction of new building)

Computer System Validation/ Equipment Qualification Provision of service regarding Deviation and Change Management, CAPA-Management, Configuration Management and Computer System Validation for a Roche/Basel production site for F. Hoffmann-La Roche. -Qualification of small devices. -Change Management -Risk Management -Creation of SOPs ( Business Continuity Management) -Configuration Management

Organization of the transfer of a help desk from India to Switzerland. 1st Level support for MES 2nd Level Support for Labeling System

Validation of Computerized Systems (Novartis) Validation of a web-based purchasing system according to the customers standards and regulations. Setting up the documentation framework and partially workout of User Requirements Specifications as well as Risk Assessments. Support of software manufacturer regarding test documentation and test performance. Accompanying the development of an electronic test system under quality aspects.

Process Validation (Novartis, Marburg): Mainly elimination of documentation gaps which have been detected during an external audit

Computer System Validation of data bases and computerized systems für Sanofi Pasteur MSD und Roche Diagnostics Deutschland GmbH

Wirtschaftsinformatik

Analytische Chemie, Verfahrenstechnik