Helping companies or teams not only meet the compliance standards - but build a Quality Culture that is inspection-ready
EVERY SINGLE DAY.
Mission
Professional, person-focused consulting for pharmaceutical quality assurance. Your trusted partner in compliance, audits, and process improvement.
Support pharmaceutical companies in complying with GMP guidelines and in strengthening their pharmaceutical quality systems and quality culture, with an optional focus on sterile manufacturing processes (CCS, Annex 1). In addition, offer tailor-made training to enhance employee knowledge. Fulfil the QP role for clinical or commercial products.
About Me
With over 30 years of experience in pharmaceutical quality assurance, I help organizations achieve regulatory compliance and operational excellence. My approach is collaborative, transparent, and tailored to your unique needs.
Known for being committed, loyal, and highly responsible, I consistently strive to deliver efficient and results-driven support across all levels of quality operations. My decisive and determined mindset allows me to tackle complex challenges with confidence and clarity. With a strong client-oriented approach, I strive to build trust, exceed expectations, and create lasting value for both internal and external stakeholders.
As a consultant in sterile manufacturing and GMP compliance, I work with pharma and biotech companies to boost quality, control contamination risks, and stay ahead of audits. Whether it’s refining aseptic processes simulation strategy or supporting cleanroom and sterile equipment construction oversight - I'm there to help things run smoothly and compliantly.
I've experience as a Qualified Person (QP) for both commercial and clinical products, ensuring compliant batch release in high-pressure, regulated environments. Beyond hands-on quality work, I’ve led quality departments and know what it takes to build and manage a strong, proactive QA organization.
I support internal and external audits, supplier qualifications, and training programs that create lasting impact.
I aim to be recognized as an honest, skilled, and reliable partner in the pharmaceutical industry, assisting both small and large companies in assuring quality and compliance. By combining expertise, flexibility, and personal attention, I foster long-term partnerships with my clients.
Please visit my Linkedin profile for further details about my background and professional experience.
Services
Expert guidance on Good Manufacturing Practice (GMP) and Quality Assurance (QA) regulations to ensure your operations meet all regulatory requirements and industry standards.
Support in designing, implementing, and optimizing PQS tailored to your organization’s needs for sustainable quality and compliance leading to the Permanent Inspection Ready status.
Comprehensive audit readiness (permanent inspection ready), mock inspections, and hands-on support during regulatory and client audits.
Support with aseptic processing techniques, aspetic process simulations (APS), cleanroom design and qualification, contamination control strategies (CCS) including Annex 1 compliance.
QP support for clinical and commercial products, ensuring compliant batch release and regulatory adherence.
Assessment and qualification of suppliers to ensure quality and compliance throughout your supply chain.
Tailor-made training programs and coaching to enhance employee knowledge and foster a strong quality culture.
Streamlining processes, implementing digital solutions, and driving continuous improvement for operational excellence.
Contact
You can contact me directly by email at [email protected] for inquiries, collaborations, or more information about my services.