124 days ago on jobs.kellyservices.ch

Quality officer

Kelly Services (Schweiz) AG

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 Please refer to JobSuchmaschine in your application

Quality officer

Kelly Scientific Resources is a competent and experienced partner of the life science industry. Our client is one of the world leading healthcare companies with headquarter in the US. In Switzerland, it is one of the most important pharmaceutical companies. From Luzern it operates for the Swiss health care market and supports more than 70 branches in the EU, the Middle East Africa, Brazil, India and China. As primary recruiting partner, we are looking for an
Quality officer
Main tasks:

  • The Quality Officer is supporting the Quality Responsible Person and deputy in the following activities:
  • Ensuring that all business is conducted in accordance with the Swiss law on Medicinal Products as well as with company policies
  • write SOPs, Work Instructions, design forms and flow-charts for controlled documents
  • Support of release process of authorized medicinal products for the Swiss market
  • Administration and Change Control of an operational pharmaceutical quality assurance system for GxP-critical areas
  • Product Quality Reviews (PQRs) / Annual Reviews:
  • ensure timely review of PQRs for authorized and marketed medicinal products, assure that time-lines for review are respected
  • file the completed and reviewed PQRs, follow-up delayed PQRs
  • Product Quality Complaints (PQCs):
  • processing of PQCs  (receipt, classification, forwarding to manufacturer, tracking, feed-back to customers, metrics, periodical evaluations)
  • timely information of pharmacovigilance, Country Lead in case of suspected adverse reactions in connection with PQCs
  • Re-packing / Re-processing:
  • control and authorize packaging instructions for re-labelling or re-packaging operations
  • assure GMP-conformity and documentation (reference samples, records)
  • Support processing of quality defects and possibly initiating measures necessary as a result, such as recalling a batch/product from the Swiss market in cooperation with manufacturing site, QA management and local Health Authorities
  • Support planning and monitoring of general GDP training of employees (initial training, GxP-awareness training)
  • Prepare check-lists and protocols for annual self-inspection and mock recall

Required expertise:

  • Higher education (e.g. Master degree) in pharmacy, medicine, biology or a comparable discipline
  • Familiar with local Swiss, European and international GXP regulations
  • Documented experience in GXP regulations
  • 1 to 2 years of experience in Quality Assurance (GMP/GDP) within pharmaceutical industry would be an asset, however position is also suitable for recent graduates
  • 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, preferably also French

This position is a limited assignment starting preferably on the 1 stof August 2016 until January 2017.
Do you recognize yourself in the described profile? Are you a motivated, confident and responsible personality who wants to work in a modern and innovative pharmaceutical company?
Apply today!
Ms Daniela Ernst, Tel. +41 (0)44 225 41 06, will be happy to answer your questions regarding the position and our client.
Kelly Services (Schweiz) AG, Kelly Scientific Resources, Löwenstrasse 29, 8001 Zürich, 
Öffnungszeiten von Mo - Fr 8h00 – 12h00 / 13h30 – 18h00