Flex needed support to optimize the area of software validation and adapt it to current regulations.The majority of my work consisted of validating software and adapting quality-relevant documents.Scope of work/Tasks:• QA responsibility for updating quality-relevant documents• Preparation and participation in internal audits• Planning and implementation of validation tasks • Documentation and implementation of validation activities in accordance with valid specifications and project planning • Creation of validation/qualification plans and reports as well as associated • risk analyses (FMEA) and test plans/reports• Review of validation/qualification documents• Creation of a concept for switching from the Computer System Validation (CSV) process to Computer Software Assurance (CSA)

Roche needed support to strengthen the V & V team to validate and qualify for equipment and test systems.Most of my work was the qualification and validation of equipment and plants, and also QA- responsibility in a long-time-project.Scope of work/Tasks:• QA- responsibility in a long-time-project together with another Side• Prepare and participation at internal and external Audits• Planning and implementation of validation and qualification tasks • Concept development for the inventory of software • Support and professional advice for the operators and users of equipment/systems during the execution of validation and qualification tasks • Documentation and execution of validation activities in accordance with valid specifications and project planning • Preparation of validation/qualification plans and reports as well as associated risk analyses (FMEA) and test plans/reports• Review of validation/qualification documents• Optimization and adaptation of methods validation plans to new SOP

Scope of work/Tasks:• Plan and execute validation activities for ERP-System and production machines• Creation and review of test documents• Creation of risk analyses (FMEA)• Development of a strategy to ensure data integrity in the company and implementation of a data integrity program

GxP ConsultingValidation & Qualification for Pharmaceutical and Medical Device IndustryAnalyze and resolve Compliance ProblemsAnalyze and resolve technical ProblemsCreate and review SOPsCreate and review Specifications and Test Documents

- Building up a Test Team for Clinical Trials (8-20 Tester)- Analyze and resolve intercultural issue - Analyze and resolve problems for global cooperation with Germany and US - Analyze and resolve technical Problems- Leading & managing group of testers (CSV) for medical devices- Educate Testers for clinical trials and manual testing- Computer systems validation of highly complex PC based medical (Class IIa)- Delivery of test documentation of spirometry diagnostic devices & ePRO equipment for market approval- Set Up test site as a trainer & supervisor- Create and review Specifications and Test Documents for Clinical Trials

- Leading & managing group of testers (CSV) for medical devices - Computer systems validation of highly complex PC based medical (Class IIa)- Delivery of test documentation of spirometry diagnostic devices & ePRO equipment for market approval- Set Up test site as a trainer & supervisor

- Sales of computers and accessories- Computer repair service- Network – and System Administration- Software Development- Software Testing / Hardware Testing- Partnership with Symantec, Novell and Seagate / Veritas- Cooperation with InterVideo, Hauppauge, MSI and AOpenStarting with a Internet Shop, go forward to a regular shop with service for Customer and Company’s.Building own Computer Systems and develop Software for Multimedia and Home Entertainment and exhibit on international Fairs. At least with 10 Employee