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. 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. 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 QA Specialist is responsible for leading quality issue investigations and writing reports in accordance with regulatory expectations. This position will be responsible for operating cross-functionally at various levels within the organization to collect necessary data and information associated with manufacturing, laboratory, and support services deviations. This position will lead root cause analysis sessions with SME's and determine and implement associated corrective actions to prevent the deviation from recurring. This role is expected to maintain on-time closure of all deviations and CAPAs and to drive management of these records across the organization. Also, this position may lead and/or participate in improvement project teams across a variety of departments.
- Ensure the GMP-compliant production of active ingredients and drugs for clinical trials and market launch
- Lead non-conformance investigations impacting Quality assurance, Quality Control and other service functions
- Define and leads cross-functional and cross-site investigation teams
- Execute High or Medium Impact investigations, to determine root cause(s) and ensure timely completion of the investigation.
- For product related investigations, ensure samples for investigations are available in accordance with defined sampling plans and retained as per local site's procedures, if applicable
- Coordinates Supplier Investigation, with the relevant personnel as applicable
- Develops the Corrective/Preventive Action and Effectiveness Check plans as applicable and ensures their timely approval and completion.
- Assigns the activity owners for Corrective/Preventive Action Activities.
- Oversees completion of corrections and Corrective/ Preventive Action Activities per committed timelines.
- Initiates Extension requests (if needed).
- Ensure effectiveness of Corrective/Preventive Action
Who we are looking for
- University degree in pharmacy, natural science, medicine, or equivalent
- Work experience in a GMP related environment, preferably in Quality Assurance, Quality Control or Compliance
- Experience and understanding of Root Cause approach and methodology
- Good communication skills in English language
- Communication skills in German is a plus
- Ability to work in a diverse and changing environment
- Flexibility, accuracy, and reliability
- Ability to organize and prioritize, and to continuously review priorities
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!