Petra Pfaeffle, M.Sc.

As Quality Assurance Director / Qualified Person, Petra Pfaeffle is responsible for the management of projects related to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Quality Assurance activities, and development of Quality Management Systems for clients.

Petra also acts as Qualified Person (Responsible Person) for clients in Switzerland. She is responsible for the release of drug products to the Swiss market, as well as maintaining and supervising the clients’ Quality Management System.

She brings more than 20 years of experience in the pharmaceutical and medical device industry including eight years as registered Qualified Person in Switzerland. Her long-term industry experience and strong understanding of operational processes, especially in small and medium size pharmaceutical companies, allow her to provide hands-on experience and expertise in all aspects of quality assurance.  Her expertise includes the set up and revision of Quality Management Systems, establishment of compliance processes, employee training, set up of supplier qualification programs, and audit conduction.

Petra provides valuable input preparing for and accompanying clients through authority inspections.  She also supports implementing adequate corrective actions afterwards.

As a certified auditor with seven years of worldwide experience, Petra can conduct audits at drug product manufacturers, warehouses, distributors, and agents.

Prior to joining VCLS, Petra worked for several pharmaceutical manufacturing companies (e.g. Swisscaps, Ivers-Lee, Acino Supply) as Head of Quality Management and Qualified Person. She was responsible for maintaining the companies’ Quality Management System and for releasing drug products. As Head of Quality Management and Qualified Person at Lamprecht Pharma Logistics, a global pharmaceutical distribution company, she gained an in-depth knowledge of Good Distribution Practices. She notably was responsible for identifying suitable storage premises for pharmaceutical products during the major project of relocating the company’s office and their rented warehouses to a new site. Petra sets up a new Quality Management System, including validation of various processes, as well as the qualification of the different warehouse areas for which she managed to obtain a new manufacturing and importation authorization and a wholesale distribution authorization.

Petra started her career working as a Consultant for a GxP consultant service office in Mannheim, Germany (later known as gempex) where she was responsible for the validation of active substance manufacturing processes at BASF.

She earned a MSc in Applied Chemistry from the University of Applied Sciences in Mannheim (Germany).

Petra is based in Lausanne office.