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CSV Consultant & CSV Quality Assurance Manager& Project Manager

offline
  • auf Anfrage
  • 4123 Allschwil
  • DACH-Region
  • de  |  tr  |  en
  • 01.07.2024
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Kurzvorstellung

Highly versatile and proactive CSV Manager and Project Manager with a proven track record in life sciences. Bringing over 3 years of experience in managing qualification and validation projects, ensuring GxP compliance,and leading teams

Auszug Referenzen (3)

"Created GxP compliant documentation for IT infrastructure qualification and SAP S4/HANA, OpenText validations."
CSV Consultant
Kundenname anonymisiert
Tätigkeitszeitraum

8/2022 – 9/2023

Tätigkeitsbeschreibung

Role: Project Leader of IT Infrastructure Qualification and PQM
• Created GxP compliant documentation for IT infrastructure qualification and SAP S4/HANA, OpenText validations.
• Authored SOPs for IT infrastructure, URS for applications, ICRA, VP, ERES, DS, FS, FRA, TRM, VR, IQ, OQ, PQ, UAT test scripts, and plans, such as test & strategy, migration plans and operational handbooks.
• Actively participated in CAPA and Deviation investigations, Change Management, and their closure.

Eingesetzte Qualifikationen

SAP S/4HANA, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Qualitätsdokumentation

"Conducted retrospective validations of the Eplan application with interfaces to SAP S4/HANA, ensuring compliance with SOPs and Gamp 5."
CSV Consultant
Kundenname anonymisiert
Tätigkeitszeitraum

1/2022 – 7/2022

Tätigkeitsbeschreibung

• Conducted retrospective validations of the Eplan application with interfaces to SAP S4/HANA, ensuring compliance with SOPs and Gamp 5.
• Authored VP, ERES, DS, FS, FRA, TRM, VR, IQ, OQ, PQ, UAT test scripts, and plans with reports

Eingesetzte Qualifikationen

Eplan, Qualitätsdokumentation, Qualitätsmanagement / QS / QA (IT), SAP S/4HANA

"Led the development and definition of design control processes for agile medical software according to customer standards (EN ISO 13485/21"
CSV Consultant
Kundenname anonymisiert
Tätigkeitszeitraum

1/2021 – 12/2021

Tätigkeitsbeschreibung

Role: PQM
• Led the development and definition of design control processes for agile medical software according to customer standards (EN ISO 13485/21 CFR 820).

Eingesetzte Qualifikationen

ITIL, Agile Methodologie, Qualitätsmanagement / QS / QA (IT), Qualitätsdokumentation

Qualifikationen

  • 21 cfr 11
  • annex 11
  • Data Integrity
  • DIN EN ISO 13485
  • GXP
  • Infrastrukturarchitektur
  • Projektleitung / Teamleitung (IT)1 J.
  • Prozessvalidierung
  • Qualitätsdokumentation2 J.
  • SAP S/4HANA1 J.

Projekt‐ & Berufserfahrung

CSV Consultant
Kundenname anonymisiert, Ismaning
8/2022 – 9/2023 (1 Jahr, 2 Monate)
Life Sciences
Tätigkeitszeitraum

8/2022 – 9/2023

Tätigkeitsbeschreibung

Role: Project Leader of IT Infrastructure Qualification and PQM
• Created GxP compliant documentation for IT infrastructure qualification and SAP S4/HANA, OpenText validations.
• Authored SOPs for IT infrastructure, URS for applications, ICRA, VP, ERES, DS, FS, FRA, TRM, VR, IQ, OQ, PQ, UAT test scripts, and plans, such as test & strategy, migration plans and operational handbooks.
• Actively participated in CAPA and Deviation investigations, Change Management, and their closure.

Eingesetzte Qualifikationen

SAP S/4HANA, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Qualitätsdokumentation

CSV Consultant
Kundenname anonymisiert, Goettingen
1/2022 – 7/2022 (7 Monate)
Life Sciences
Tätigkeitszeitraum

1/2022 – 7/2022

Tätigkeitsbeschreibung

• Conducted retrospective validations of the Eplan application with interfaces to SAP S4/HANA, ensuring compliance with SOPs and Gamp 5.
• Authored VP, ERES, DS, FS, FRA, TRM, VR, IQ, OQ, PQ, UAT test scripts, and plans with reports

Eingesetzte Qualifikationen

Eplan, Qualitätsdokumentation, Qualitätsmanagement / QS / QA (IT), SAP S/4HANA

CSV Consultant
Kundenname anonymisiert, Bergisch Gladbach
1/2021 – 12/2021 (1 Jahr)
Life Sciences
Tätigkeitszeitraum

1/2021 – 12/2021

Tätigkeitsbeschreibung

Role: PQM
• Led the development and definition of design control processes for agile medical software according to customer standards (EN ISO 13485/21 CFR 820).

Eingesetzte Qualifikationen

ITIL, Agile Methodologie, Qualitätsmanagement / QS / QA (IT), Qualitätsdokumentation

Zertifikate

Computer System Validation
Tüv Süd
2023
Introduction to Data Engineering,
IBM
2023
Pharmaceutical Engineer PT25 2
Concept Heidelberg
2020
ISO 13485:2016 Quality Management Systems for Medical Devices (2020)
Alison
2020

Ausbildung

Master’s Degree in Business Engineering Management
diploma
Zurich University of Applied Sciences
2011
Zürich
Bachelor’s Degree in Mechanical Engineering
diploma
Lucerne University of Applied Sciences and Arts
1999
Lucerne

Über mich

• Lead IT Infrastructure Qualification project and function as PQM for writing GxP related life cycle documentation for IT infrastructure qualification and validations of applications such as SAP S4/HANA, OpenText, Eplan with interfaces in accordance with SOPs and Gamp 5. I was responsible for writing the following documents: SOP for IT infrastructure, writing URS for applications, writing ICRA, VP, ERES, DS, FS, FRA, TRM, VR and IQ, OQ, PQ, UAT test scripts and plans such as test & strategy and migration plan and their reports. I actively participate in CAPA and Deviation investigation and Change Management and participate in their closure.

• Responsible for developing and defining Design Control processes for the validation of medical software

• Serving as a verification and validation engineer for the Neurostatus scoring project, involving the implementation of a test plan and test strategy document, which outlined scope, objectives, timelines and focus of software testing for functional, regression, user acceptance and stress testing

Weitere Kenntnisse

Adept at managing all stages of life cycle documentation and the project management while providing leadership to colleagues and maximising project performance. Obtained a master’s degree in business engineering management, as well as a bachelor’s degree in mechanical engineering, which involved the completion of a thesis about the optimisation of a medical oxygen concentrator.

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Türkisch (Muttersprache)
  • Englisch (Fließend)
  • Italienisch (Grundkenntnisse)
Reisebereitschaft
DACH-Region
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
unbedingt
Profilaufrufe
475
Alter
50
Berufserfahrung
4 Jahre und 11 Monate (seit 01/2020)
Projektleitung
1 Jahr

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