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Specialist Quality Systems // Johnson & Johnson

Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 135,000 people.

Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site, with its approx. 500 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and bacterial based therapeutic products.

The Quality Systems Specialist position aim to support the maintenance of the Quality Issue Management Process (QIMP) by ensuring its continuous improvement, as well as, providing training on Root Cause Analysis and on the design of compliant Corrective/Preventive Action(s) and Effectiveness Check Plans. In addition, the position also aims the participation as a team member in a site project by supporting the Document Owners in defining and writing their processes in compliance with the local Quality Management System Framework and Good Documentation Practices.

Main Responsibilities

  • Provide system and process training for new users on the QIMP Process: issue description (including compliance writing requirements), issue impact assessment, root cause analysis, CAPA and Effectiveness Checks plans definition
  • Provide continuous support for the users in using the system and coaching them in the QIMP process adherence
  • Support the Process Owner on the users management, and in the organization of local implemented Boards for managing ETS records completion according to the defined KPIs
  • Review and approves routine incoming process documents assuring compliance with the current Quality Management Systems requirements as defined in the local Quality Manual
  • Mentor Document Owners in defining their processes, suggesting processes improvements/KPIs and writing a compliant documentation ensuring Good Documentation Practices
  • Contribute to the creation and maintenance of documentation and records for area of responsibility - may include Standard Operating Procedures (SOPs), Work Instructions (WIs), and other quality documentation.

Who we are looking for

  • University degree in Natural Science, Medicine or Pharmacy
  • Knowledge of cGMP regulations and general Quality Systems processes such as Nonconformances, Change Controls, Documentation Management and Training
  • Work experience in a GMP environment, preferably in Quality
  • Good English communication
  • Strong ability in dealing with IT systems such as TrackWise
  • Strong written, oral, and presentation skills.
  • Ability to work in a matrix environment

This job based in Bern, Switzerland will initially be limited to approx. 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, progressive, and collaborative environment, then send us your application today. Or give us a call if you have any questions!

#diversity #50plus

Specialist Quality Systems // Johnson & Johnson

Bern
Vollzeit, Teilzeit, Befristet

Veröffentlicht am 14.12.2021

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