Audits & Mock Audits
Know Where You Stand – Before It Matters.
Independent, experienced audit support for pharmaceutical, biotech and life-science companies.
From supplier and internal audits to mock audits and inspection readiness assessments – get an experienced GMP/GDP Lead Auditor exactly when you need one.
An Audit Should Create Clarity – Not Just Findings.
Audits are more than a compliance exercise.
Done well, they provide an independent view of your systems, identify potential risks and weaknesses, and help your organization understand where action is really needed.
Whether you need an experienced auditor to independently conduct an audit or want to assess your own organization before an upcoming inspection, I provide practical, risk-based audit support based on many years of hands-on experience in the pharmaceutical industry.
The goal is not simply to identify findings – but to provide a clear and practical basis for improvement.
How I Can Support Your Team
Supplier Audits
Independent assessment of suppliers and service providers based on applicable requirements and your organization's quality standards.
Audit Preparation · Audit Execution · Documentation · Audit Report
Internal Audits
Independent evaluation of internal processes and Quality Systems to identify gaps, risks and opportunities for improvement.
GxP Processes · Quality Systems · Documentation · Compliance
Mock Audits
A realistic independent assessment of your organization before the real audit or inspection takes place.
Identify potential gaps before an inspector or customer does.
GMP/GDP Audits
Audit support based on extensive experience in regulated pharmaceutical environments.
GMP · GDP · Quality Systems · Suppliers · Processes
Audit Preparation
Support with defining audit scope, reviewing relevant documentation and preparing an efficient, risk-based audit approach.
Audit Findings & Follow-up
Clear documentation and categorization of observations, with practical input to help your organization understand priorities and next steps.
Want to Know What an Auditor Might Find?
Don't wait for the real inspection to find out.
A mock audit provides an independent view of your current state and helps identify potential weaknesses before they become inspection findings.
I can review selected processes, systems or broader areas of your Quality Management System from an auditor's perspective and provide a structured assessment of potential gaps and risks.
Independent perspective. Practical feedback. No surprises.
Flexible Audit Support – Exactly When You Need It
You may not need additional permanent audit capacity.
You may simply need an experienced auditor for:
one supplier audit
one internal audit
an independent mock audit
a specific audit program
a period of increased workload
That's exactly what flexible consulting is for.
A defined scope. Senior expertise. No long-term commitment.
Experienced on Both Sides of the Audit Table
As a GMP/GDP Lead Auditor and Head of Quality Systems, I have extensive experience conducting internal and external audits as well as supporting and hosting regulatory and customer inspections.
This combination provides an important perspective: understanding what an auditor needs to assess – while also knowing the operational reality of the organization being audited.
GMP/GDP Lead Auditor Qualification
GMP Auditor – Concept Heidelberg (2013)
GMP Lead Auditor – Concept Heidelberg (2014)
Audit Planning & Preparation · Audit Execution · Third-Party Audits · Communication & Conflict Prevention · Audit Programs · Categorization of Audit Observations
Need an Experienced Auditor?
Whether you need an independent supplier audit, want to assess your internal Quality Systems or would like to know how inspection-ready your organization really is – let's discuss the scope you need.
One audit. One project. Or flexible ongoing support.