# Yunus Emre Aksoy

Yunus Emre Aksoy is a remote worker on Himalayas, Solutions Architect at Egeli Lifesciences, based in Germany.

Source: https://himalayas.app/@yunusemreaksoy

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

| Detail | Value |
| --- | --- |
| Availability | Looking for a job |
| Location | Germany |
| Authorized to work in | Germany, Canada, Turkey |
| Salary expectations | 65k+ EUR |
| Job categories | IT Project Manager, IT Project Manager, Production Manager, Solutions Architect |
| Skills | Serialization, EU FMD, DSCSA, Tulip, GxP, CSV Testing, IQ+, FAT, SATs, MES, Werum PAS X, SAP ERP, Qualification and Validation (CQV) Services, Project Management, Problem Solving, Continuous Improvement, CQV, Pharmaceutical Manufacturing, Pharmaceutical Compliance, GAMP 5 Best Practices, ISPE GAMP Guidance |
| LinkedIn | https://https://www.linkedin.com/in/yunus-emre-aksoy-64460725/ |

## About

```text
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

### Solutions Architect (current)

Egeli Lifesciences. Mar 2024 - Present

```text
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.
```

Skills: Serialization, EU-FMD, DSCSA, Tulip, No-Code, Low-Code, Technical-Specifications

### IT Project Manager

Advanco. Apr 2022 - Mar 2024

```text
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.
```

Skills: Serialization, GxP, CSV, IQ+, FAT, SATs, Pre-Sales, SME

### Production Manager

[Novartis Turkey](https://himalayas.app/companies/novartis). Oct 2015 - Jun 2018

```text
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.
```

Skills: 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

```text
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.
```

Skills: Manufacturing-Operations, SAP, MES, Werum-PAS-X, CQV, Quality-Documentation, Team-Management

## Education

### College

College, Computer Programming and Analysis. 2021 - 2022

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

### University

Bachelor, Chemical Engineering. 1999 - 2005

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

## Tech stack

- Jira
- XML
- Confluence
- cq
- SQL

To contact Yunus Emre, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire).

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