QA/CAPA Expert // 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 Johnson & Johnson 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 120,000 people.

Johnson & Johnson Innovative Medicine is a global pharmaceutical 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. 600 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.

Main Responsibilities

• Lead personnel and activities to establish and maintain quality systems NCs and CAPAs. This includes trending, analysis and reporting of quality metrics.
• Serves as site trainer for the NC/CAPA process
• Update and maintain Procedures, Work Instructions, and Forms for the quality system
• Serves as a Point of Contact with the global NC/CAPA Business Processes Owners for assuring J&J requirements and standards are in place
• Investigate, lead, and own site activities related to the NC/CAPA processes
• Monitors site metrics and proactively takes action to ensure timeliness targets are met or exceeded
• Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes Has thorough understanding of process criteria and regulations and business impact of decisions and actions
• Lead monthly CAPA Review Board meetings and create status reports (monthly & quarterly reports, data analysis and trending for management)
• Lead weekly Root Cause Analysis Board and provide support to the NC/CAPA users for a compliant execution of the process
• Participate in ongoing identification of quality indicators/ metrics and development of improved data collection methods
• Lead continuous quality system improvement efforts, including maintaining project schedules
• Participate in and lead where necessary during the preparation and execution of any internal and/or external audits

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
• Profound experience in facilitating and performing Root Cause Analysis
• 5 - 8 years working experience in a GMP environment, preferably in Quality
• English and German (fluently)
• Strong ability in dealing with IT systems such as TrackWise
• Strong written, oral, and presentation skills
• Experience in biologicals manufacturing technologies is preferable
• Experience or certification in Lean/Six methodologies preferred

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