Specialist Microbiological Product Quality // Johnson & Johnson
Posted: 29 Jan 2024
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:
- Provide Microbiological Quality Assurance expertise to site units to ensure appropriate state of microbial control.
- Ensure that manufacturing processes, meet Microbiological Quality Assurance principles and requirements.
- Ensure that new manufacturing processes, or process changes meet Sterility Assurance principles and requirements.
- SME for non-conformities and CC related to environmental monitoring and microbiological excursions
- Review and approval of non-conformities, CAPAs, and Change Controls related to environmental monitoring and microbiological excursions
- Support the maintenance, development, and improvement of Microbiological Quality processes.
- Support site Quality Aseptic Processing Oversight Program
- Review of executed batch records for aseptic process simulation
- Review and approval of documents, e.g. SOPs, work instructions and risk assessments, master batch records
- Ensure the GMP-compliant production of active ingredients and drugs for clinical trials and marketed product
- Ensure that deliverables assigned to Product Quality team as part of projects are successfully achieved on time
- Contact person for production, development, and quality control for product quality related topics
- Support the achievement of KPIs
- Support the execution of external inspection and audits from local and foreign Health Authorities, including the FDA, and customers
Who we are looking for:
- University degree in pharmacy, natural science, medicine, or equivalent
- Work experience in a GMP related environment, preferable in Quality is a major plus
- Strong microbiological background
- od communication skills in English language
- Communication skills in German is a plus
- 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 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!