Matus Kominka Email & Phone Number

Prague, Czechia

Prague, The Capital, Czech Republic

Ensuring process design, implementation, deployment and tools design, build, testing and deployment in compliance with non GxP regulatory requirements and Novartis non GxP related: policy, standards and procedureProvisioning of clear, implementable requirements in the area of controls and activities related to the overall compliance framework and is co-responsible for embedding these in the project deliverablesEnsuring close alignment with eCompliance on the requirements related to GxP/CSVTight coordination of all ISRM resources assigned on the program and overall accountability for positive and timely contribution to achieving the project objectives within the given timelines and expected level of qualityDefinition of an overall framework for embedding controls and any IT compliance requirements within the program in close alignment with the eCompliance and the Program LeadProviding clear and pragmatic guidance and strong Leadership to the team and ensuring that the various ISRM roles contribute to the right-by-design approach at each step of the design, thus avoiding misalignment at the times of approving deliverables Coordinating the various ISRM associates on program and ensuring consistency of work being done and review of feedbacksRegularly updating the SEL on progress, challenges, decisions to ensure alignment and management support at all timesActing as a senior, strategic thinking advisor to program Lead on matters related to the compliance framework Establishing a strong partnership with the eCompliance Lead to ensure a consistent approach to the compliance framework within the program for GxP/CSV and all other controlsEstablishing a strong partnership with the program/project Manager and team Leads Coaching and advising the program/project quality Managers

Basel Area, Switzerland

Managing quality and compliance work on business and IT projectsSupporting project teams in compliance with the quality policy - CSV, data privacy, security during project planning, execution and closureStrong GxP knowledge and experience with FDA CSV / Part11 compliance / GMP /GCP /GLP, ISO 9000/ Six sigmaProject evaluation, documentation and project reviews.

Prague, The Capital, Czech Republic

Specification determination and application of the applicable Quality Manuals to ensure Programs/Projects continuously meet their specified corporate and regulatory internal and external requirementsEnsuring the operation of the Programs/Projects is in accordance with corporate and regulatory standards including ICE, GxP, SOX, Information Security (ISEC), IT Security, Data Privacy and Business Continuity Management (BCM)Taking care of risk assessments/reports to be produced for Report quality and project status with possible issues to be presented to Steering CommitteeConducting, monitoring, and supporting Project Quality Reviews- evaluation if projects and deliverables fulfill the requirements for quality- uncovering errors or deficiencies in processes and deliverables- identification of strengths and opportunities for improvementPreparation, review and/or approval of Program/Project documentation- consistency with quality standards- quality of deliverables- obtaining acceptanceDriving end-to-end quality governance in projects, including their handoverSupporting and coaching project managers in the application of ICE methodology and project management procedure in order to deliver business solutions aligned with strategic initiatives

Prague, The Capital, Czech Republic

Managing Director of Datalynx s.r.o. in Prague with focus on market in Czech Republic, Slovakia, Poland and Hungary

Prague, The Capital, Czech Republic

Acting as reference point for the entire Prague team on operational needsRecruitment activities (leading Interview agendas, organizing the organization meetings, etc.)Creation of the Objectives of the team membersParticipation in Objective Meetings review and end of the year Performance review meetingIdentification of Training needs for team members and triggering of training organizationPerforming review objectives with team members when needed

Prague, The Capital, Czech Republic

Ensuring the operation of the Programs/Projects is in accordance with corporate and regulatory standards including ICE, GxP, SOX, Information Security (ISEC), IT Security, Data Privacy and Business Continuity Management (BCM)Conducting, monitoring, and supporting Project Quality Reviews- evaluation if projects and deliverables fulfill the requirements for quality- uncovering errors or deficiencies in processes and deliverables- identification of strengths and opportunities for improvementPreparation, review and/or approval of Program/Project documentation- consistency with quality standards- quality of deliverablesDriving end-to-end quality governance in projects, including their handover

Basel Area, Switzerland

Freelancer Consultant via D-ploy GmbHActing as Single Point Of Contact (SPOC) and coordination of ongoing activities (business, IT, 3-rd party vendor) following GxP standardsAccountable for delivery of validated outputs (system, products, documents)Realization of defined business objectives and CTQ tasks (Critical to Quality)Definition of test and validation strategy and plans and overall management of adherence to the testing and validation processesResponsibility for the computerized system and the quality of the dataEnsuring correct definition of business processesContinuous monitoring the implementation of validation requirementsPerforming quality control throughout the entire life cycle of the projectReview and update of project/product documentation (SOPs, GxP qualification documents, etc.)Following 21 CFR (parts 11, 210,211, 820, 860, 861) and GAMP 5

Prague, The Capital, Czech Republic

- Leading the team of QA Managers with main focus on process improvement across various projects- Major stakeholder in new reporting system design, with focus on standardized reports across company- Driving JIRA customization to accommodate inter-team cooperation to meet specific requirement of individual team across organisation including definition of guidelines.- Employing standardized quality management practices and tailored methodology for the needs of a given project- Lead non-project efforts such as education and evaluation of external contractors and testers- Providing consultations to external teams on localization process, internationalization and issue reporting system- Major stakeholder in vendor SLA specification as well as monitoring of KPIs- Managing external resources, driving process and workflow standardization initiatives to further optimize the end to end localization process with focus on quality and productivity- Responsible for software, documentation and telephony localization quality assurance and internationalization of multiple product portfolio- Leading the work of the distributed software quality assurance teams for individual products- Supervise, mentor and grow QA Managers, Test Leads and Testers- Drive good software quality management practices, own & implement quality process improvements across the company- Effectively collaborate in a fast paced environment with multiple business teams (Development Management, Product Management, etc.)- Communicate project status, testing vision to product management

Prague, Czech Republic

Coordination of QA and testing process on localization projects Process improvement and documentation of new standardsTest Strategy Plan creation in combination with overall Testing ScheduleSpecification of test cases and instructions for test lead and testers Managing teams of testers and monitoring quality and productivityAnalysis, design and improvement of processes, standards and toolsCooperation with development teams on internationalization issuesHandled overall ownership of the new localization process, prepared documentation, delivered relevant training and presentations to other teams

District Brno-City, Czech Republic

Definition of unified company Graphic Look Design of promotional materials (posters, business cards, T-shorts…)Desktop Publishing of company magazine including graphics creation

District Brno-City, Czech Republic

Analysis of SDLC documents (PRD, FSD, TEC, etc.) - Requirement testing - Specification clarificationHigh and low level manual test case design - Test case maintenance - Regression testingCooperation on design of test automationTest environment specificationContribute to estimation of projects delivery dateCreation of project proposal documentsFrequent communication with development and product management teams

District Brno-City, Czech Republic

Responsible for software and documentation localization leading 5 to 10 overlapping projects annually, with complete management responsibilityPromoted to Project Team Manager based on localization experience and deeper knowledge of quality management, assumed ownership of optimized localization quality process across various projectsCoordinated with Engineering and QA teams, and client PM to define localization exit criteria for each project with focus on quality and client’s satisfactionManaged and coordinated between specialized per-project virtual teams with members in different geographical locations and time zones, handled full accountability for their work flow and outputSuccessfully drove initiative to reduce localization costs on projects with a process optimization focused on improving quality and productivity of project teams Ongoing forming and training of project team including hiring process during team expansion based on individual project needs

Quality and productivity checkDevelopment of assigned testers by trainingsPersonal face to face interview each quartalCanon electronic manuals - Managing preparation and testing of HTML based manuals - Big projects using 60 testers - Localization to 26 languages - Effort to create specialized team for specific projects * Easier to manage then 60 inexperienced students - Documentation of processes and presentation for managementMS Windows 7 localization - Test-cases for functional testing of localized builds - Managing regression testing - Localization to 16 languagesMS Office 14 localization - Optimalization of workflows for image localization - Manage remotely image team in Vietnam - Trainings for employees in Vietnam - Localization to 16 languagesMS educational FLASH presentations - Preparation and testing of flash video presentationsCISCO e-learning materials - Testing of HTML based e-learning courses with interactive questionsAdobe CS4 and CS5 - Test-cases for functional testing of localized builds - Preparation of special screencaptures for translatorsOthers - Many small projects localized only to couple of languages with specific requirements

Master, Ssme: Service, Science, Management And Engineering

Activities and Societies: Master Thesis: Managing External Resources in Multicultural Environment Managing in Reality course, IBM IDC.

Bachelor, Graphic Design And Typography