freiberufler Computer System Validation (CSV), Commissioning Qualification & Validation(CQV), Qualification of Pharma Equipment, Test Manager Experience - Pharmaceuticals Branch - Freelancer auf freelance.de

Computer System Validation (CSV), Commissioning Qualification & Validation(CQV), Qualification of Pharma Equipment, Test...

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  • 60489 Frankfurt am Main
  • Weltweit
  • en  |  de
  • 16.02.2024

Kurzvorstellung

23+ years experience in IT Industry
12+ years experience in Computer System Validation (CSV), Commissioning Qualification & Validation (CQV) and Test Manager experience at Global Pharma comanies Bayer, AbbVie, Nordmark, Merz Pharmaceuticals.

Qualifikationen

  • FDA 21 CFR Part 11
  • GAMP 5
  • Medizin
  • Pharmazie
  • Prozessvalidierung
  • Testing (IT)

Projekt‐ & Berufserfahrung

Computer System Validation Team Lead
AbbVie Pharmaceuticals R&D, Deutschland (Globales, Rheinland Pfalz
1/2017 – 2/2020 (3 Jahre, 2 Monate)
Life Sciences
Tätigkeitszeitraum

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.

Eingesetzte Qualifikationen

Testing (IT), Prozessvalidierung

Computer System Validation Team Lead
Bayer Healthcare AG, Köln
5/2015 – 12/2017 (2 Jahre, 8 Monate)
Life Sciences
Tätigkeitszeitraum

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.

Eingesetzte Qualifikationen

Prozessvalidierung

Test Manager (Verification and Validation)
Medical Intelligence Medizintechnik GmbH (ELEKTA), Schwabmünchen, Bayern
11/2012 – 4/2014 (1 Jahr, 6 Monate)
Medical device industry, Medical devices, Radiation Therapy, Oncology, X-Ray imaging, Medical Imaging
Tätigkeitszeitraum

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.

Cardiac monitoring devices, medical devices
Cardiac Science Inc., U.S.A, USA
12/2011 – 11/2012 (1 Jahr)
Gesundheitswesen
Tätigkeitszeitraum

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.

Test Manager
Assurant Health Insurance Inc, U.S.A, USA
10/2010 – 9/2011 (1 Jahr)
Health Insurance
Tätigkeitszeitraum

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

Test Manager
Quantum Retail, Inc, U.S.A, PUNE
11/2009 – 9/2010 (11 Monate)
RETAIL
Tätigkeitszeitraum

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)

Test Manager
National Grid, Plc, Great Britain, Great Britain
1/2009 – 10/2009 (10 Monate)
Energy and Utilities, Electricity, Oil and Gas, Electricity Smart meter, Smart Metering
Tätigkeitszeitraum

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.

Test Team Leader
Chrome Data Solutions, U.S.A, Mumbai
6/2005 – 6/2006 (1 Jahr, 1 Monat)
Automobil, Cars customization software
Tätigkeitszeitraum

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.

Test Team Leader
T-Mobile (Deutsche Telekom), Deutschland, Saarland
11/2004 – 6/2005 (8 Monate)
Telecommunication tariff, Telecommunication billing
Tätigkeitszeitraum

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.

Test Team Leader
AT& T (SBC-Pacific Bell) California, USA, California
10/2003 – 10/2004 (1 Jahr, 1 Monat)
Telecommunication IVR (Interactive Voice Response) application
Tätigkeitszeitraum

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

ISTQB Agile Tester Certification
2019
ISTQB® Certified Professional
2018
Masters degree in Business Studies (Computer Systems)
2009

Ausbildung

Computer Systems
Ausbildung
2009
Pune

Über mich

• Ich bin ab sofort verfügbar.

• Über 23 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.

• 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 Player1

• 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

•Extensive computer system validation and IT compliance experience at major Life Sciences/ Healthcare / Pharmaceutical companies such Bayer Healthcare, Elekta and AbbVie Pharmaceuticals R&D.

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

Persönliche Daten

Sprache
  • Englisch (Muttersprache)
  • Deutsch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
5978
Alter
47
Berufserfahrung
24 Jahre und 4 Monate (seit 11/1999)
Projektleitung
23 Jahre

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