About the Johnson & Johnson MedTech Companies – Vision (Uppsala site)
Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity. Johnson & Johnson Vision is a leading global optical company that develops life changing techniques for all ages. We provide eye surgeons and their patients with a complete solution that includes a range of advanced products and services developed to help people of all ages with sight defects. We offer market leading technique for laser surgery, equipment for cataract operations and intraocular lenses. We also offer a program for education and support that help eye surgeons to master the full range of the technology.
Validation Leader QA Johnson & Johnson Vision Uppsala Site
In the position as Validation Leader QA you will be the leader of validation activities within Johnson & Johnson Vision, Uppsala site. In this role, you are also running Quality Management wich means to: maintain, develop and improve quality management processes and ensure that quality management processes meet company requirements related to validation processes.
As the Validation Leader QA, Uppsala, you are also responsible for review and approve validation documentation, lead change cases related to validation process for process and product as well as for quality assurance of deviations and CAPA, including quality assurance deviation and CAPA investigations and quality assurance of corrective and preventive action plans during validation. You act as our Validation Subject Matter Expert (SME) within projects in the business.
This position is based in Uppsala where you are a part of a small team of specialists with various specialist areas and reporting to the QA/QS Manager. We are a dedicated team with different skills in an ambitious company where everyone stands up for each other and contributes to a positive atmosphere. We look forward to having you in our team! Welcome with your application today!
Objectives of the Position
- Ensure that Validation standard procedures within the Uppsala site are in compliance with internal J&J policies and standards and external regulatory requirements.
- Issue validation documentation for validation of process and product.
- Ensure standards validation documentation templates according to internal J&J standard procedures for validation of process and product.
- Review and approve accounting and governing documents within validation process and validations.
- Decide on initiation of deviation and CAPA investigations according to internal procedures.
- Review and approve investigations, action plans and implementation of validation deviations.
- Participate as a validation leader QA representative in projects.
- Perform training related to validation process.
- Support in external audits related to validation process.
What you will need to succeed
You dare to make your own decisions and enjoy planning and carrying out your work yourself. To succeed in the role you are structured and quality-conscious. You are adaptable and solution oriented and are happy to come up with new insights. As a person, you are driven and proactive, have a good ability to work independently as well as collaborate with others. The work requires that you are detailed, flexible and enjoy working according to set time targets. The pace of work can sometimes be high, and it is important that you can plan your work while at the same time be open and flexible for re-prioritization.
We believe our candidate has excellent communication, interpersonal, organizational and analytical skills.
A minimum of a bachelor’s degree (required). An advanced degree such as MBA, MSc/Ph.D. in Science, Engineering, or a related field (merit).
A minimum of 3-5 years’ experience of Validation in Pharmaceutical or Medical device industry (required).
- Experience of; understanding and application of principles, concepts and practices of GMP/ISO regulations such as CFR210, 211 and ISO 13485:2016 (required).
- Proficient in Swedish and English language (required).
- Uppsala work location (required).
If you are interested in this position, please apply with an updated CV and Cover letter in English. The selection process will start during the posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in the Nordics are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
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At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.