Quality Responsable Person
Kelly Services
Luzern, CH
vor 4 Tg.

Our client is a multinational pharmaceutical company employing a diverse group of highly skilled scientists, engineers, technicians and process specialists from more than 15 nations.

On their mission to bring new innovative medicines to patients as fast as possible, while applying highest quality standards to all activities they offer an exciting opportunity to join their biological drug development and manufacturing site.

Quality Responsable Person

The main responsibilities are :

  • Responsible to Swissmedic and company management to ensure GxP compliance for operations of the Swiss company subsidiary
  • Awareness and implementation of applicable regulations and dissemination to relevant colleagues
  • Developing and maintaining an operational pharmaceutical quality assurance system for GxP-critical areas
  • Developing and maintaining a local documentation system that encompasses working instructions, descriptions of procedures and protocols
  • Ensuring that all business is conducted in accordance with the Swiss law on Medicinal Products, as well as with company policies
  • Ensuring that all regulatory approvals and authorizations are obtained for the legal entity for import, wholesale, and export of pharmaceuticals
  • Ensuring the traceability of purchases and sales of medicinal products and recording the necessary information related to this task
  • Ensuring a procedure for recalls is in place
  • Contact person for Technical Quality Agreements defining GxP responsibilities
  • Notification of critical trends and emergent quality deficiencies to Swissmedic
  • Decision making for all quality issues
  • Managing the Swiss Quality Assurance Department at the local office
  • Responsibilities for the Swiss Market

  • Release of commercial products for the Swiss market independently from commercial functions, (primarily based on the release documents of the QP of the manufacturer)
  • Designated point of contact for processing of product quality complaints and suspected CDT cases (counterfeits / diversion / tampering)
  • Processing quality defects and deciding on or possibly initiating measures necessary as a result, such as recalling a batch / product from the Swiss market in cooperation with the manufacturing site, Quality Assurance management and local Health Authorities
  • Taking decisions concerning destruction of returns
  • Overall responsibilities for GxP activities in the re-labelling / re-packaging of pharmaceuticals
  • Planning and performing of internal audits
  • Planning and monitoring of general GDP training of employees (initial onboard training, GxP-awareness training)
  • Direct quality supervision of the local contractor for warehouse and distribution services / secondary packaging and obtain insight into the business processes relevant for Good Distribution Practices (GDP)
  • Requirements :

  • Higher education (e.g. Masters degree) in pharmacy, medicine, biology or a comparable discipline
  • At least 5 years of experience in Quality Assurance (GMP / GDP) within the pharmaceutical industry
  • Minimum 3 years of supervisory experience
  • Applicant must fulfill requirements to be appointed the Quality Responsible Person (fachtechnisch verantwortliche Person) by Swissmedic
  • Intimately familiar with local Swiss, European and international GxP regulations
  • Direct experience interacting with Health Authorities and managing Health Authorities inspections
  • Excellent analytical and problem solving skills, based on science, data and understanding of regulatory requirements in a complex and evolving environment;
  • ability to apply sound risk management

  • Fluency in German and English is required, preferably also French
  • Are you interested? Then apply now! For telephone inquiries Daniela Ernst, at 044 225 41 06 is happy to answer your questions.

    Kelly Services (Schweiz) AG, Kelly Scientific Resources, Löwenstrasse 29, 8001 Zürich

    Opening hours Monday - Thursday 8h00 12h00 / 13h30 17h30 - Friday 8h00 12h00 / 13h30 17h00

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