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Yunus Emre Aksoy

@yunusemreaksoy

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IT Project Manager and CQV Lead with 15+ years of pharmaceutical enterprise experience.

Germany

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At Egeli Lifesciences, I design serialization software focused on Level 1 to Level 4 interfaces. I translate EU FMD and DSCSA regulatory requirements into IT technical specifications and use Tulip to design solutions around client needs.

Previously, I managed serialization software implementation projects in GxP environments at Advanco and executed CSV testing, including IQ, CQ, OQ, FAT, and SAT. I also supported pre-sales as an SME, identifying pain points and presenting technical perspectives.

At Novartis Turkey, I supervised the Production Department and oversaw production planning, process validation, and technology and process transfers. Earlier, at Biofarma and Bilim Pharmaceuticals, I led manufacturing operations and served as Lead SME and Key User for the Werum PAS-X MES implementation. My process optimization work received a Make a Difference Award.

Experience

Work history, roles, and key accomplishments

Current

Solutions Architect

Current

Egeli Lifesciences

Mar 2024 - Present (2 years 6 months)

Designing serialization software focusing on Level 1 to Level 4 interfaces. Translating regulatory requirements (EU FMD and DSCSA) into IT technical specifications and designing solutions using the Tulip no-code, low-code platform.

Serialization EU FMD DSCSA Tulip No Code Low Code Technical Specifications

IT Project Manager

Advanco

Apr 2022 - Mar 2024 (1 year 11 months)

Managed serialization software implementation projects in the GxP environment (Production sites, Warehouses, 3PL). Executed CSV testing (IQ, CQ, OQ, FAT, SAT) and involved in pre-sales activities as an SME.

Serialization GxP CSV IQ+FAT SATs Pre Sales SME

Production Manager

Novartis Turkey

Oct 2015 - Jun 2018 (2 years 8 months)

Supervised the Production Department with more than 100 employees, defined and monitored KPIs and operational targets. Oversaw BOMs in SAP and Master Batch Records in MES, managed capacity planning, and led process validation and technology transfer projects.

Production Management KPIs SAP MES Capacity Planning Process Validation Technology Transfer Cost Management Operational Efficiency

Early Production Roles

Biofarma & Bilim Pharmaceuticals

Jul 2007 - Apr 2015 (7 years 9 months)

Led solid and semi-solid manufacturing operations, managed 50+ employees, and coordinated production plans. Reviewed quality documentation in SAP, served as Lead SME for Werum PAS-X MES implementation, and involved in CQV projects.

Manufacturing Operations SAP MES Werum PAS X CQV Quality Documentation Team Management

Education

Degrees, certifications, and relevant coursework

College

College, Computer Programming and Analysis

2021 - 2022

Completed a college program in Computer Programming and Analysis in Toronto.

University

Bachelor, Chemical Engineering

1999 - 2005

Bachelor's degree in Chemical Engineering from a university in Izmir, covering chemical processes, process design, production systems, and engineering principles.