Responsible Person / Qualified Person & Regulatory Affairs

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Responsible Person / Qualified Person & Regulatory Affairs

The purpose of Morgan Sindall 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

  • Our QP Competence Centre Zurich

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  • 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.

  • Florian Ebert

    Qualified Person / Quality Management

    After several years as Clinical Operations Lead/Project Manager of clinical trials he changed to the medical department where he worked as Qualified Person and Regulatory Affairs Manager for several companies. Further to his practical experience, Florian Ebert currently participates in a MAS program in quality leadership.

  • 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 Managemet

    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

    Using her expertise in quality management, Melanie Greuter completes GMP- and GDP-relevant duties. She has acquired also in-depth knowledge of GCP by implementing clinical trials. Her background supports her ability to create high quality scientific documents, to manage the interface with clients and to monitor numerous projects in parallel.

Contact us:

qualified-person@morgansindall.ch

Schaffhauserstrasse 354 | 8050 Zürich | Schweiz

Contact person

Further Capabilities

  • Laboratories

    Intelligent environments and smart processes. Innovative integrated laboratory solutions delivered by our expert engineers, scientists and architects.

  • Virtual Reality & 3D Solutions

    Our clients demand the latest and most effective digital tools in the delivery of our designs.

  • Process Engineering

    We understand our clients’ operational and quality process needs, applying industry leading ideas from some of the best minds in our field.

  • Project Management & Controlling

    With our hands-on approach to project delivery strategies, our experienced project managers and their teams define and manage schedules, budgets and deliverables throughout the project lifecycle.

  • Consulting

    We offer expert, individually tailored consultant services to our clients in the feasibility stages of new facilities or processes, tech transfers and scale-ups.

  • Building Services

    Flexible and high performance building services that are dynamic and responsive to the environmental needs of our clients.

  • Facility Design

    We specialise in full facility design, integrating complex functional processes and laboratories throughout their entire life cycle.

  • CQV Services

    We support our clients with efficient commissioning, qualification and validation activities and ensure a punctual system handover for a successful start-up.

  • GxP Compliance Services

    Our experts have in-depth knowledge in all GxP areas and support you in complying with regulatory requirements.

  • Construction Management & HSE

    Our robust CM tools and skilled teams enable us to develop specific plans that deliver projects safely and to scope, time and budget.

  • Functional Safety Management

    We ensure our clients meet their regulatory safety obligations. We offer complete lifecycle functional management; bringing process and operational expertise together with the latest analysis tools.

  • Technology Transfer & Scale-up

    We design and incorporate innovative processes that can be scaled up or easily transferred to other locations.

  • Asset Lifecycle Management

    We support our clients in managing their facilities and deliver operational savings in their work processes, from installation through to decommissioning.

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