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Elevating Quality, Ensuring Compliance

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Meet Your Pharma Quality Consultant

My name is Deniz Erdogan and I am a pharma quality consultant who specializes in helping companies achieve excellence in Quality Assurance. With 20 years of professional experience in the industry, I have a deep knowledge and understanding of the pharmaceutical market. 

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I am passionate about quality assurance and strive to always deliver the best solutions for my clients. My international experience includes both local and global roles, allowing me to provide a unique and comprehensive approach to problem solving.

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My objective is to support pharmaceutical clients on quality management strategies, compliance frameworks, and regulatory requirements, ensuring adherence to Good Manufacturing Practices (GMP) and other relevant guidelines.

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Contact me to find out how I can help you as a trusted consulting partner!

Profile & Skills

  • Highly knowledgeable and results-driven Pharma Quality Consultant with 20 years of experience and a proven track record of implementing effective quality management systems and driving compliance within the pharmaceutical industry.

  • In-depth expertise in Good Manufacturing Practices (GMP) and quality assurance.

  • International experience in local and global organizations.

  • Exceptional analytical and problem-solving skills to identify areas of improvement and provide strategic recommendations for quality enhancement.

  • Hands-on experience in coordination and execution of quality processes.

Expertise Areas

  • Good Manufacturing Practices (GMP)

  • Quality assurance

  • Quality management system

  • Quality and regulatory gap assessments

  • Quality auditing and self-inspection

  • Supplier Qualification/Audit

  • Complaints and deviations handling

  • Root cause analysis and CAPA implementation

  • SOP development and revision

  • Training

  • Change control management

  • Quality remediation projects

Selected Experiences

​QA Consultant 

Client: ARTBIO

Establishing eQMS and support creation of SOPs, protocols, reports.

 

Head of QMS

Novartis Advanced Accelerator Applications - France

Established a tailored and compliant radiopharmaceutical Quality Management System (QMS) and ensure the full integration to Novartis QMS following the acquisition.

 

QA Europe Project Lead

Novartis External Supply Organization - Germany
Translated global external supply strategies into specific projects and drive Operational Excellence through local project teams. Led Brexit project for EU retest laboratory transfers.

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Head QA Shopfloor

Novartis Kundl Manufacturing Site - Austria 
Responsible for QA oversight and GMP compliance in production areas of sterile and non-sterile penicillin and cephalosporin products. Led operational excellence projects to reduce lead time for batch release.

 

Quality Compliance Manager

Novartis Kurtkoy Manufacturing Site - Turkiye
Responsible for compliance with quality manual and GMP requirements, implement and maintain QMS.

 

Internal and External Audit Supervisor

Abdi Ibrahim Pharmaceuticals - Turkiye

Enhanced supplier qualification program and implemented a risk based approach for external and internal audits.

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Contact

Let's connect for getting acquainted and collaborating in new and exciting opportunities.

  • LinkedIn

©2023 by Deniz Erdogan Consulting and Coaching 

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