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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. 

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.

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.

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

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.

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.

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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