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Mehmet Dogan

@mehmetdogan

Project manager in regulated life sciences, managing Polarion ALM validation and IT infrastructure qualification in the cloud.

Switzerland
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On a medical-device company project, I managed the validation of Polarion ALM and an IT infrastructure qualification project. I created the required lifecycle documentation and coordinated project teams and stakeholders.

I also managed IT application migration and cutover for pharmaceutical divestitures, preparing documented evidence of handovers and reporting to steering committees.

For a medical-device company, I defined CSV and ESV strategy, created validation documentation, and supported the local QM/QA team in preparation for audits.

My work spans regulated life-sciences IT, including computer system validation, quality management, IT service management, and security. I hold CISA, ITIL v3, and PRINCE2 certifications.

Experience

Work history, roles, and key accomplishments

BC

CSV Consultant

Biotechnical Company

Jan 2022 - Jun 2022 (5 months)

Implemented SAP ECTR interface to EPLAN and defined CSV and test strategy. Created and supported documentation including VP, URS, FS, DS, RA, TP, IQ, OQ, PQ, TR, VR.

IP

Project Manager

IT Service Provider

Apr 2020 - Jul 2021 (1 year 3 months)

Implemented DocuSign e-signature application on cloud. Managed project charter, contracts, technical approach, and ensured training and documentation were established.

BI

Project Manager

Biotech Industry

Oct 2020 - Feb 2021 (4 months)

Managed retrospective CSV validation of SAS platform. Prepared project charter, defined CSV and technical approach, and coordinated project team and stakeholders.

MC

Program Management

Multinational conglomerate company

Oct 2019 - Mar 2020 (5 months)

Designed and implemented a qualified multi-cloud managed service for COMOS. Defined strategy, reviewed contracts, and trained over 200 sales representatives.

IP

Lead Auditor

IT Service Provider

Oct 2018 - Dec 2018 (2 months)

Conducted GAP assessment of local datacenter, IT security measures, and GDPR. Defined strategy, interviewed stakeholders, and prepared recommendations and action plan.

IP

Lead ISO Auditor

IT Service Provider

May 2016 - Aug 2016 (3 months)

Implemented QMS for ISO 9001:2015 and ISO/IEC 20000-1:2011 certifications. Conducted as-is analysis, defined solutions, and finalized certification process.

PI

Project Manager

Pharmaceutical Industry

Sep 2015 - Mar 2016 (6 months)

Managed a divestiture program to provide copies of validated records from an Enterprise Quality Management Software. Defined scope, managed project, and ensured test strategy.

PI

Project Quality Lead

Pharmaceutical Industry

Jan 2015 - Aug 2015 (7 months)

Managed divestiture program to provide copies of validated records from Trackwise. Conducted scope analysis, created lifecycle documentation, and ensured qualified environment and test strategy.

CS

Head QMS & PM

Consulting Services

Dec 2013 - May 2014 (5 months)

Managed transition of infrastructure support service to a new operating model. Set up QMS and IT security baselines, implemented best practices, and trained team members.

PI

Process Expert

Pharmaceutical Industry

Dec 2012 - Feb 2014 (1 year 2 months)

Set up a new operating model and onboarded new virtualization IT infrastructure (vBlock) with high availability capabilities. Consolidated expectations and coordinated with stakeholders.

Education

Degrees, certifications, and relevant coursework

Cologne University of Applied Sciences logoCS

Cologne University of Applied Sciences

Diplom Informationswirt (FH), Information Management

Diplom Informationswirt (FH) / Degree in information management from Cologne University of Applied Sciences, Germany.

IC

ISBB Cologne

Vocational Training as Foreign Trade Merchant, Foreign Trade

Vocational training as foreign trade merchant via Volkswagen Vertriebszentrum West at ISBB Cologne, Germany.

HM

Höhere Handelsschule Köln Modemannstrasse

Vocational Baccalaureate Diploma, Economics

Commercial College Cologne – Vocational Baccalaureate Diploma in Economics.

Tech stack

Software and tools used professionally

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