Patrick Nieuwenhuizen is a director/senior consultant at PharmaLex. He is a quality professional with a microbiology and sterile manufacturing background and over 25 years’ experience in the pharmaceutical industry. Patrick has worked for several global pharmaceutical and biotechnology companies across a variety of platforms including biologics, sterile fill finish and solid oral dose.

Patrick has been involved with several site and laboratory expansion projects from construction design through to method transfer and operational readiness, and has provided quality, sterility assurance and microbiology oversight where relevant during these projects. In addition to site responsibilities, he is involved in several corporate initiatives such as Sterility Assurance Council and the roll-out of corporate standard programs that required collaboration and communication across multiple diverse sites for the improvement and maintenance of organizational quality standards. He has been involved with audits facing several competent authority inspections including the HPRA, FDA, ANVISA, Chinese FDA and Canadian Health Authority inspections.