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20 часов назад

Responsible Person (Pharmaceutical Quality)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Switzerland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR

Responsible Person (Pharmaceutical Quality): Ensuring compliance with Swiss pharmaceutical legislation and GDP/GMP standards for the release of medicinal products and advertising materials with an accent on legal accountability and product safety. Focus on managing regulatory relationships with Swissmedic, overseeing pharmacovigilance systems, and authorizing market releases.

Location: Hybrid in Sempach, Luzern, Switzerland

Company

hirify.global is a global leader in the healthcare sector, providing essential medical solutions through its various production sites.

What you will do

  • Independently release or reject imported medicinal products and market returns for the Swiss market.
  • Ensure strict compliance with GDP, GMP, and Swissmedic requirements.
  • Oversee change controls and deviations related to medicinal products.
  • Manage the legal release of pharmaceutical advertising material.
  • Act as the primary subject matter expert during ISO and GxP audits and inspections.
  • Coordinate pharmacovigilance systems, including case management and safety communications.

Requirements

  • University degree in Pharmacy, Life Sciences, or a related field.
  • Recognized qualification and experience as a Responsible Person (according to Swissmedic Guideline I-SMI.TI.17d).
  • Recognized qualification as a responsible person for advertising (according to AWV Art. 25).
  • In-depth knowledge of Swiss pharmaceutical legislation (HMG, AMBV, AWV) and GDP/GMP standards.
  • Fluent in German and English (French is a plus).

Culture & Benefits

  • Flexible working hours with the option to work from home.
  • Extended paternity leave and financial contributions for family support.
  • Financial support for further training, language courses, and a modern learning platform.
  • On-site amenities including a restaurant with fair pricing and free parking.
  • Employer-covered NBU (Non-Occupational Accident Insurance).
  • Health workshops and contributions to sports and health-promoting activities.

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