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 260 operating companies in more than 60 countries employing approximately 135,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
Janssen Vaccines belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 40,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 400 people of over 25 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products and therapies.
The Quality Systems Specialist position aims 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 at 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.
- Provide system and process training for new users on the QIMP Process: issue description, impact assessment, root cause analysis, CAPA and Effectiveness Checks plans definition.
- Provide 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 ensuring 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
- Profound knowledge of cGMP regulations and Quality Systems processes especially Nonconformances, Change Controls, Documentation Management and Training
- Experience in facilitating and performing Root Cause Analysis
- Work experience in a GMP environment, preferably in Quality
- Very good communication in English and German
- Strong ability in dealing with IT systems such as TrackWise
This job is based in Bern, Switzerland and will initially be limited to 12 months. If you are interested in working for a global leading health care company, in a highly dynamic and flexible work environment, then send us your application today. Or give us a call if you have any questions!
Randstad (Schweiz) AG, c/o Janssen