HIGH SUN GxP CONSULTING

GMP Consulting & GxP Compliance Services

– My Path – Your Advantage –

Empathic · Experienced · Results-Oriented

Portrait of Klaus Hajszan, biotechnologist and expert in GxP compliance and quality management, founder of HIGH SUN GxP CONSULTING e.U.

About Me: My Path – My Offering

I am Klaus Hajszan, founder of HIGH SUN GxP CONSULTING, with more than 15 years of experience in senior roles within the pharmaceutical and biotech industry.

My career path has taken me from Quality Control (QC) and Quality Assurance (QA), through the role of Qualified Person (QP) under §7 of the Austrian Medicines Act (AMBO), to executive functions as Managing Director, Test Site Manager in GLP environments, and Trial Facility Manager in GCP structures.

This long-standing practice forms the foundation of my current work in GMP consulting and GxP compliance. I know regulatory requirements in detail, but I also understand how to design processes that are practical, inspection-ready, and economically sustainable.

Who I Am and What I Stand For

Passion

For me, quality is not just an obligation but an opportunity. I view regulatory requirements not only as rules to follow but as a chance to make processes more efficient, safer, and more sustainable.

My aim is to position compliance not as an obstacle, but as a tangible competitive advantage, especially in the GMP and broader GxP environment.

Profile

I combine leadership and technical expertise across all key areas of GxP management: QC, QA, QP, and management roles in GMP, GLP, and GCP structures, including executive leadership.

This interdisciplinary background enables me to develop strategic concepts while ensuring operational execution with a clear view of the bigger picture.

Mission

My mission is to empower companies to establish inspection-ready, efficient, and practical processes.

I align compliance, operational excellence, and business competitiveness, helping to secure long-term stability and sustainable success.

How I Work With You

Empathic

I listen carefully and take my clients’ perspective seriously. This allows me to create solutions that take both people and organizations into account.

Collaboration at eye level builds trust and provides the foundation for sustainable results.

Experienced

With more than 15 years in senior positions within the life sciences industry, I have gained a deep understanding of regulatory requirements.

Whether in QC, QA, as a QP, or in management roles such as Test Site Manager (GLP) and Trial Facility Manager (GCP), each stage has shaped my practical approach and decision-making strength. I draw on this experience to translate complex requirements into pragmatic, inspection-ready solutions.

Results-Oriented

I focus not on formalism but on solutions that make a real impact.

For me, compliance means more than simply meeting requirements. It should make processes more efficient, create real value, and deliver measurable results that stand the test of time.

GMP Consulting & GxP Compliance Services - Foundation

My Path – Foundation for GMP Consulting

– From Experience to GxP Compliance –

My professional journey through QC, QA, QP, and management roles forms the foundation of my current work in GMP consulting and GxP compliance.

This experience enables me to connect regulatory requirements with practical solutions and to help companies operate in an inspection-ready and economically sustainable way. In this way, I turn my path into your advantage.

Detailed Company Profile

Learn more about our project experience, leadership background, and GxP expertise across the life-science sector.

Company Details

Contact

We look forward to hearing from you.
Contact us for consulting or project support.
Together, we can strengthen your competitiveness!

ADDRESS

Hausbergsiedlung 30
7100 Neusiedl am See, Austria

Phone

+43 660 446 9883

E-mail

office@highsun-gxp.com

GMP Consulting Pharma & Biotech - HIGH SUN GxP CONSULTING - Klaus Hajszan

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