Responsible Person / Qualified Person & Regulatory Affairs

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Responsible Person / Qualified Person & Regulatory Affairs

The purpose of BakerHicks is to fully support life sciences companies to bring innovative medical products to patients. This is why we offer services ranging from registering medicinal products by Regulatory Affairs Experts and the analysis and Quality Control to the release of the product to the market by experienced RPs. To outsource Regulatory Affairs, Quality Control or the Responsible Person, provides the flexibility to pharmaceutical companies to remove capacity bottlenecks that arise due to the varying workload in quality assurance. Our experts for medicinal products, active pharmaceutical ingredients, excipients and food products are available on short notice and may fill gaps.

 

 

Our Services

 

 

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    Our QP Competence Centre Zurich

  • Daniela Vögeli

    Qualified Person / Quality Management

    Through her work as a group leader in analytical development, she was able to gain extensive experience in project management and regulations in the GMP environment which contributes to her current work as Qualified Person.

  • Karin Hilfiker

    Qualified Person / Quality Management / Regulatory Affairs

    Due to her work in different departments of a pharmaceutical company, she has gained valuable experience in the laboratory sector as well as in manufacturing under GMP conditions. She was able to use this knowledge to act as a competent and reliable person specifically in her position as qualified person.

  • Dr. Markus Hunziker

    Qualified Person / Quality Management

    Thanks to his motivation and willingness to learn, he has achieved constant professional development during his career. Even as Head of Quality Assurance, his ability to meet requirements and apply his in-depth knowledge has created his outstanding track record of results on his responsibilities.

  • Béatrice Pertoldi

    Qualified Person / PQR Expert

    After studying pharmacy at ETH Zurich, Béatrice Pertoldi worked in various community pharmacies. She then held various positions in the area of clinical trials (CRA / Senior CRA / Project Manager / SOP Manager / Head Quality Control) for twelve years. Since 2014, Béatrice Pertoldi has been working as Quality Manager for the support of the person in charge of technical engineering with a focus on PQR reviews, which led to the title of PQR Expert.

  • Dr. Walter Ganci

    Qualified Person / Quality Control / Analytics / Compliance

    Walter Ganci has a profound knowledge in the fields of quality control, analytics and compliance. He has an open-minded and highly responsible personality. Within his function as Qualified Person, he could achieve broad experiences in product releases of pharmaceutically active compounds, complaint handling and all aspects of quality assurance topics. Walter is a highly motivated person and is highly appreciated by his co-workers and supervisors.

  • Dr. Melanie Greuter

    Quality Manager

    She takes on GMP- and GDP-relevant tasks of Qualified Persons, as the establishment of quality management systems of pharmaceutical companies. She has acquired in depth knowledge of GCP by designing and implementing clinical trials and is able to monitor numerous projects in parallel. Her scientific background in clinical tumor biology supports her ability to evaluate and review complex data as well as to communicate it concisely. Her experience enables her to ideally manage the interface with clients.

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Further Capabilities