Şebnem ÖZTÜRK

GMP Lead Auditor | Quality Systems and Regulatory Compliance Consultant | Validation, Technology Transfer, and Audit Management Specialist

For over 20 years, I have been establishing, developing, and fully preparing production facilities for audit in accordance with GMP, GxP, FDA, EMA, ISO 9001, and PIC/S standards in the pharmaceutical, herbal product, and dietary supplement industries.

True quality is not just about regulatory compliance; it is possible with sustainable systems integrated into decision-making processes, organizational reflexes, and cultural structures. With this perspective, I build structures that foster quality within the organization, not just compliance.

From Audit Preparation to CDMO Processes

I manage CDMO projects and GMP assessments for a wide range of clients, from multinational corporations to local manufacturers;
- License transfer,
- Technology transfer,
- Outsourcing agreements,
- I actively participate in every stage of the CTD/eCTD filing process.

The systems I establish are not only "document-ready" but also "field-ready." My systems combine operational excellence and regulatory integrity within the same framework.

My Consulting Vision

My consulting approach focuses on building structures that add value not only to the organization's technical needs but also to process integrity, risk management, and internal knowledge transfer.

Thanks to my field experience in training, documentation, and internal audit processes, I produce solutions that are not only theoretical but also aligned with the dynamics in the field.

My Key Areas of Expertise :
- GMP-Compliant Quality Management Systems
- Production Facility Compliance and Audit Preparation
- Internal and Supplier Audits
- Validation (Process, Cleaning, Analytical)
- CTD/eCTD Licensing Files
- Technology Transfer and Contract Manufacturing Compliance
- Digital Quality Systems Integration
- Environmental Monitoring and Contamination Control
- ISO 9001 Integration and Continuous Improvement
- Pharmacopeia Compliance (EP, USP, BP)

My Competencies and Training :
- Certified Pharmaceutical & Biotechnology GMP Lead Auditor
(Exemplar Global & Quality Academia)
→ International expertise in audit methodology, process risk analysis, GMP compliance strategies, data integrity, and regulatory audit management.
- ISO 14644 Cleanroom Standards
- CTD/eCTD Licensing Process Training
- Quality Culture and GMP Training (EMA, FDA, TİTCK compliant)
- Data Integrity & Computerized Systems (USA – GMQA)
- SME Consulting, Transactional Analysis, and Organizational Coaching Certifications

When working with corporate structures, I make the process transparent and manageable by developing a risk map, implementation plan, and audit scenarios specific to each project. I don't just set up the system; I structure it to ensure that the organization can maintain it with its own internal resources.

"I combine compliance with clarity, structure with strategy, and oversight with a human approach. Because true trust begins with well-trained teams."