Karolina Tomczyk

Experience

• 

  International School of Poznan

  Jan 2007 - Jan 2008

  Physics teacher

  Physics teacher in Junior High School

• 

  Forschungszentrum Jülich

  Feb 2008 - Jan 2011

  Scientific employee

  - Soft Matter- Polymers, Colloids- Light and Neutron Scattering, UV-VIS Spectroscopy, FCS Techniques- High Pressure Techniques

• 

  Pharma Quality Europe

  Feb 2012 - Jun 2014

  Consultant - Validation Specialist

  Summary:- Computerized System Validation (CSV), GxP, Quality Assurance- GAMP® 5, EudraLex Vol. 4 Annex 11, FDA Title 21 CFR Part 11, ICH Q9- SAP-QM implementationProjects:CSV for: Laboratory, Production, Backup and Archive, Training Data Base SystemsCustomers and Locations: TEVA Kfar Saba (Israel), TEVA Caronno (Italy), GAMBRO Breve (Italy), EGIS Budapest (Hungary), MERCKLE BIOTEC Ulm (Germany)- establishing full V-cycle validation documentation according to GxP standards- tests planning and executionSHAPE LIMS project: Full lifecycle SAP QM implementation in area of stability processesCustomer: SANDOZ, Kundl (Austria)- FRS review and new developments verification/testing- OQ test scripts preparation and test execution- end users roles (authorizations) setting according to defined Business Process Flow (BPF)- training materials preparation and end users trainings conducting- workshops preparation- end users support after go-liveSHAPE LIMS project: Data migration in SAP-QM implementationCustomer: SANDOZ (HEXAL), Barleben (Germany)Global LIMS remediationCustomer: TEVATraining Mangement structure preparation in Sandoz E-Learning System (SELS)Customer: SANDOZ (EBEWE), Unterach (Austria) Weniger anzeigen

• 

  QbiQ AG, München

  Sept 2014 - Apr 2017

  Consultant - Validation Specialist

  Summary:- Validation coordination- Serialization and Product Tracking (SPT) – Track & Trace- SAP-AII, SAP-ECC testing for Serialization Track & Trace implementation- SAP-QM master data maintenancce supportProjects:Validation Coordinator Support in Track & Trace BioInject ProjectCustomer: SANDOZ BioInject, Schaftenau (Austria)- creating and review of the validation documentation: test specifications, Functional Risk Assessment (FRA)- change and deviation management- performing and supervision of test activities (IQ, OQ, PQ, SAT)Update of the User Requirements und Functional Specifications StructureCustomer: ROCHE Diagnostics GmbH, Penzberg (Germany)- update of the User Requirements Specification and Functional Specification documentation structure in IBM Rational DOORS 9.5 system (splitting of specifications for relevant functional areas)Data maintenance in SAP-QM business support in area of release processesCustomer: SANDOZ, Kundl (Austria)- maintenance of Inspection Plans and Certificates of Analysis (CoAs) in SAP-QM Weniger anzeigen

• 

  Systec & Services GmbH

  Jan 2017 - Feb 2019

  Validation Consultant

  Summary: ▪ Serialization and Product Tracking (SPT), Track & Trace - Implementation at Packaging Lines ▪ Computerized System Validation (CSV); GxP; Quality Assurance ▪ GAMP® 5; EudraLex Vol. 4 Annex 11; FDA Title 21 CFR Part 11; ICH Q9 ▪ creation / review / approval of the V-cycle validation documentation (incl. risk assessment and traceability matrix) and functional specification ▪ planning and coordination of test cycles ▪ execution of test activities (FAT, SAT) ▪ system test automatization with TestComplete ▪ cooperation with Seidenader Maschinenbau GmbH, Markt Schwaben (Germany) ▪ customers: SANDOZ, Kundl und Schaftenau (Austria), Târgu Mureș (Romania) Weniger anzeigen

• 

  IVU Traffic Technologies

  Jan 2019 - now

  Senior Software-Ingenieur

  Summary: ▪ QA product acceptance ▪ creation and execution of system tests, smoke tests and performance tests; review of integration tests; participation in customers’ tests (FAT) ▪ test planning and monitoring; coordination of test team ▪ system test automatization with Ranorex