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Computerized System Validation (CSV), Commissioning Qualification & Validation(CQV), Qualification of Pharma Equipment, SAP...
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- 60489 Frankfurt am Main
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- en | de
- 26.08.2024
Kurzvorstellung
- 12+ years experience in Computer System Validation (CSV),
- Commissioning Qualification & Validation (CQV)
- SAP Test Manager experience at Global Pharma comanies Bayer, AbbVie, Nordmark, Merz Pharmaceuticals.
Qualifikationen
Projekt‐ & Berufserfahrung
1/2017 – 2/2020
Tätigkeitsbeschreibung
Senior position, validation team lead and responsible for overall computer system validation activities including computer system validation of chromatography data software GxP systems from ThermoFischer & Waters applications such as CDS Chromeleon, CDS Empower & NuGenesis SDMS.
Ensure quality & timelines and plan completion of deliverables to meet the go-live dates.
Facilitating FMEA for GxP systems with key stakeholders
Create & execute Validation Test Protocols (OQ) and UAT protocols (PQ) in HP ALM /Quality center tool and log defects, traceability matrix, project summary/system certification summary.
Testing (IT), Prozessvalidierung
5/2015 – 12/2017
Tätigkeitsbeschreibung
Responsible for managing the overall verification & validation activities for business-critical applications.
Worked closely with regulatory compliance team, QA and key stakeholders to get the relevant validation deliverables completed and signed-off.
Review and understand SOP (Standard Operating Procedures), Quality Management system, verifications & validation documentation procedures.
SAP Solution manager tool used as test management tool.
Status reports for the management on weekly and monthly basis.
Prozessvalidierung
11/2012 – 4/2014
Tätigkeitsbeschreibung
1. Responsible for managing the overall verification & validation activities for Radiation therapy project Europa Release 2 using Waterfall methodology.
2. Responsible for test planning the integration of Elekta MOSAIQ, Brainlab ExacTrac X-ray imaging system with Elekta Linacs to treat cancer tumors using image guided radiation therapy.
3. Developed test cases based on system requirements, understand SOP(Standard Operating Procedures) and Quality Management system, performed clinical validation in hospitals, responsible for defect management in JIRA tool, created status report for management meetings.
12/2011 – 11/2012
Tätigkeitsbeschreibung
1. Managed complete verification & validation for project HeartCentrix which was a device connectivity solution for Cardiac monitoring devices with EMR (Electronic Medical Record)
2. Responsible for creation of test plan, test cases, maintaining traceability matrix, test environment set-up, formal clinical validation, defect management, FDA 510k filing DHF documentation.
3. Reviewed & validated all the information in Clinical User Guide for the medical devices software.
4. Worked with software services team for medical devices software installation.
5. Developed the verification & validation review checklist for cardiac monitoring devices software.
10/2010 – 9/2011
Tätigkeitsbeschreibung
1. Responsible for managing the testing of health insurance claims processing system to process group insurance policies.
2. Managed a team of 15 test engineers for functional and system testing.
3. Developed test cases based on functional requirement specifications, traceability matrix, defect tracking using Quality centre 9.2, create test report & status report for weekly & monthly meeting.
4. I was responsible for managed the testing team of 15 test engineers
11/2009 – 9/2010
Tätigkeitsbeschreibung
1. Responsible for overall testing the Product 'Q' which was a retail forecasting, order planning, allocation and replenishment for a large retail company in Great Britain. This project was based on Agile Scrum methodology.
2. Test management based on agile scrum, review feature backlog, created test cases based on user stories, test execution, monitor status of sprints, defect management in JIRA tool, performed regression testing, status reports.
3. Worked with Rally (Agile project management tool) and Confluence(Collaboration and document management tool)
1/2009 – 10/2009
Tätigkeitsbeschreibung
1. Responsible for overall testing of smart electricity meter, created the test plan & test cases based on system specification, set-up the test environment, worked with software development team to implement Zigbee interface, SMS for electricity usage, FTP and firmware upgrades for smart electricity meter, defect management, weekly testing status reports. This project was based on Waterfall methodology.
2. Developed test lab for testing smart energy meters at National Grid.
6/2005 – 6/2006
Tätigkeitsbeschreibung
1. As Test Manager, I was responsible for understanding system requirements for project Carbook fleet which was an automobile e-commerce application developed in Java JSP, JDK 1.4 and SQL Server 2000.
2. I was responsible for test plan creation, creation & execution of test cases for various customizable configurations and features, test environment set-up, defect management in Bugzilla, worked with development team to implement features and fix defects, provide test status reports for management meetings.
3. I was responsible for managing the testing for all feature customizations and configurations to enable the customer to configure a car model within a particular brand/make/model.
11/2004 – 6/2005
Tätigkeitsbeschreibung
1. As Test Team Leader, I was responsible for creating performance test scripts for telecom applications Live test –T-COM and CRM-C using Segue Silk performer.
2. Created test scripts for verifying functionalities such as tariffs, products, billing information for internet & telephony. I was responsible for automated performance testing - silk performer.
10/2003 – 10/2004
Tätigkeitsbeschreibung
1. Responsible for managing the testing for project Single System Image telecom application which was primarily an IVR (Interactive Voice Response) application developed in Visual Basic 7.0, DB2.
2. Developed test plan, test cases for front end functionalities, work with systems engineering team to review test strategy, test environment set-up, defect management in Test director, weekly status reports.
Zertifikate
Ausbildung
Pune
Über mich
• Über 25+ Jahre Erfahrung im Bereich IT davon 12 Jahre im Bereich Computer System Validation (CSV), Commissioning Qualification & Validation (CQV) and SAP S/4 HANA Upgrade experience bei Globale Pharma Unternehmen Bayer, AbbVie, Nordmark, Merz Pharmaceuticals.
• Experience in Siemens SIMATIC PCS 7 for controlling and monitoring Bioreactors. Qualification Protocol creation and execution using PCS7.
• Praktische Erfahrungen in diversen Branchen, wie beispielsweise Life Sciences (Pharma & Medizintechnik - Computer System Validation), E-Commerce, Versicherung, Telekommunikation, Retail, Automobilindustrie und Energietechnik.
• Fur allem das V model, Wasserfall model und Agilen ansatz Scrum bin ich zu Hause.
• Erfahrung in STLC (Software Testing Life cycle) und im Führen großer Testteams
• Ich habe unbefristet Niederlassungserlaubnis /Arbeitserlaubnis für Deutschland.
• Arbeitserfahrungen in Deutschland (Bayern, Saarland), USA, England
• Vertieftes Wissen im Bereich Krankenversicherung, HIPAA 5010 und ICD-10 Codes
• Spezielle Arbeitserfahrung in der Radiotherapie, Röntgenbildgebung und in der Integration
von Geräten zur Überwachung der Herzfunktion mit elektronischen Patientenakten
• Kenntnisse zu FDA Regulatorien (CFR 21), sowie weitere internationale Standards in der
Medizintechnik: ISO ISO 13485, ISO 14971, IEC 62304
• Routine im Arbeiten nach unternehmensinternen standardisierten Prozessen (SOPs)
• Kenntnisse von Zulassungsprozessen nach FDA 510(k) und CE Zertifizierung durch TÜV Deutschland
• Gute kommunikative und interaktive Fähigkeiten, lösungsorientiert, ehrlich und integer sowie in der Lage unter Druck zu arbeiten und ein großer Team Player.
• Abgeschlossene Deutschkurse der Niveaus A1, A2 und B1 der Sprachschule Inlingua
• Erfolgreicher Einsatz als Test Manager / Test Lead für folgende Auftraggeber:
Elekta GmbH, Germany
Assurant Health, USA
Cisco Systems Inc, USA
AT&T (SBC Pacific Bell) Inc, USA
Marks & Spencer plc, Great Britain
National Grid, Transco plc, Great Britain
T-Mobile (Deutsche Telekom), Germany
Testmanagement:
Intensive Erfahrung im Anleiten von Testteams, im Planen von Tests, im Erstellen und Korrekturlesen von Testreports, im Erstellen von Traceability Matrizzen, im Gestalten von Testaufbauten, in der Testausführung, in der formalen Verifikation und Validierung sowie der klinischen Validierung innerhalb von Krankenhäusern
Schlüsselkompetenzen:
Branchen E-Commerce, Versicherung, Medizintechnik, Telekommunikation, Retail, Automobilindustrie und Energietechnik
Programmiersprachen Java, C, C++, Java 2.0, Java (JDK1.2, J2EE, Servlets, JDBC)
Testwerkzeuge HP Quality Centre 9.2, JIRA v6.0.8
Agile Tools Confluence, Rally, JIRA v6.0.8
Werkzeuge & Techniken MS Projects, VISIO 7.2, MS Office
Datenbanken Oracle 12c, SQL SERVER 2014, MS-Access 2013 15.0
EMR/EHR Elekta MOSAIQ
Weitere Kenntnisse
FDA Readiness Documentation erfahrung.
• ISTQB Certified Foundation level and ISTQB Certified Agile Tester.
•Experience in laboratory testing and Chromatography data software GxP systems from ThermoFischer & Waters applications such as CDS Chromeleon, CDS Empower & NuGenesis SDMS
• International working experience in Germany, USA, United Kingdom, Austria & India.
• Good knowledge of FDA regulations 21 CFR Part 11, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, FMEA and GAMP5 guidelines.
• Worked on Radiotherapy, X-ray imaging in Medical Oncology and Cardiac monitoring devices integration with EMR (Electronic medical Records) as well as on Elekta Oncology EMR MOSAIQ.
• Implemented Standard Operating Procedures (SOP’s) and processes in a regulated (GxP) and non-regulated (non-GxP) environment at major medical and pharmaceutical companies.
• Extensive experience in complete STLC (Software Testing Life cycle) in Waterfall model and Agile Scrum.
• Managed large testing and validation teams located at multiple geographical locations.
• Demonstrated good communication and collaboration skills, problem solving capability, honesty and integrity, ability to cope with pressure and a great team player.
• Actively participated in pre-sales activities as well as proposals for new clients by doing presentations to new customers. Additionally, ramp-up and increase resources in existing client accounts.
• I have successfully managed verification and validation activities as Validation Test lead / Test Manager for following clients:
Bayer Healthcare
AbbVie Pharmaceuticals R&D
Elekta GmbH
• Experience in Siemens SIMATIC PCS 7 for controlling and monitoring Bioreactors. Qualification Protocol creation and execution using PCS7.
Persönliche Daten
- Englisch (Muttersprache)
- Deutsch (Fließend)
- Europäische Union
- Schweiz
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