Qoncept GmbH offers Quality and Technical Management Consulting Services for the Healthcare Industry

├╝ber uns

Quality and Technical Management Consulting Services

Our mission is to provide high quality consulting on key areas of quality and technical management to ensure compliance and sustainability of our clients' business. We offer project and interim management throughout the life cycle for Pharma, OTC products as well as medial devices in the following fields.

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Development

We provide services for the completion of important launch requirements in the areas of

  • compliance assessments
  • quality risk management
  • supplier evaluation
  • validations and qualifications
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Launch

To ensure a successful launch we will support your interfaces between development and operative functions by providing

  • assistance in preparation of technical documents
  • quality management system implementation
  • auditing services
  • third party management
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Product Maintenance

To maintain your marketed products and regular production we offer

  • product change management
  • product transfer management
  • outsourcing
  • compliance assessments
  • assistance in technical document updating
  • third party management
  • qualified person services

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About us

Katja Dube, founder and head of Qoncept GmbH, brings more than 10 years of professional expertise from the healthcare industry to her clients. She has served as a member of the production site management team and also has people management experience both in head office and production sites.

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Katja is a dynamic management professional with advanced knowledge in quality management disciplines, excellent technical knowledge of CMC, GMP and other guidelines as well as technical expertise for product manufacturing processes.

She gained experience for the product range of RX products (aseptic solutions, solids, semi-solids), OTC products, vitamins, cosmetics and medical devices.

Katja also led complex, cross-functional projects proving strong intercultural orientation and ability to work in or with multinational teams demonstrating cross-functional communication and interpersonal skills. In particular she worked together with the regions North America (USA, Canada) and Latin America (mainly Argentina, Mexico, Brazil, Guatemala and Venezuela). Additionally she has a strong record as to increasing profitability and improving operational efficiencies within managed departments or projects.

She is a Pharmacist by training with a PhD in Pharmaceutical Technology and Biopharmacy from the University of Kiel, Germany. She fluently speaks German, English and Spanish.

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