Quality Specialist - Bern

Sr Associate Specialist Quality Operations (CapEx)

Caring for the world one person at a time inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, which is anchored in the internationally applicable Credo. 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, 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. 400 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:

• Ensuring that applicable GMP requirements for equipment, rooms, systems, and utilities? design and
  qualification / validation are met within CapEx projects
• On time review of calibration, maintenance and change notifications? related documentation
• On time review and approval of qualification and validation documentation
• Contact person for C&Q for all equipment / systems / utilities related topics
• Ensuring that Q Ops activities required for new product introduction of product commercialization are performed on time
• Planning of the relevant activities
• Supporting Operations in ensuring that a product is ready for being manufactured under GMP conditions (GMP readiness)
• Supporting GMP-compliant production of active ingredients and drugs for clinical trials and market launch
• Reviewing and approving non-conformances, CAPAs, and Change Controls
• Ensuring the relevancy and effectiveness of corrective and preventive actions
• Supporting the collection of KPIs to measure Quality and Operations? performance
• Writing, reviewing and approving process documents (e.g. SOPs, work instructions, job aids, process
  descriptions, etc.) and risk assessments
• Supporting internal and external audits
• Supporting the execution for risk management activities for the site
  
  Who we are looking for:

• University degree in pharmacy, natural science, medicine, or equivalent
• At least 1 year of working experience in Quality department in pharmaceuticals, biotechnologies or
  chemistry industry
• Good communication skills in both German and English language
• Excellent communication and teamwork skills
• Ability to work in a diverse and changing environment
• Flexibility, accuracy and reliability
• Ability to prioritize and to continuously review priorities
  
  This job based in Bern, Switzerland will initially be limited to December 2023 with extension possibilities. 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!