Qualified Person (QP), Xbrane Biopharma
Mpya Sci & Tech AB / Kemiingenjörsjobb / Stockholm
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hela Sverige Are you someone with a strong quality mindset who is passionate about building quality systems and quality cultures? Do you have qualification for and experience from QP responsibilities? Are you ready to join a company that has an innovative product line and a vibrant culture? Then this is for you!
By joining Xbrane, you will be part of a biopharmaceutical drug development company with the mission to ensure the access of biologics to an underserved patient population, enabling global health equality. Xbrane is now seeking for a new colleague with QP qualification and experience to further strengthen the quality team. You will join a diverse team in an entrepreneurial workplace with opportunities for extensive networking.
Xbrane is an innovative company developing biosimilar products. Xbrane's partner, the German pharmaceutical company STADA, just launched Ximluci, the first biosimilar product developed by Xbrane, in the European market.
The Role
Xbrane's manufacturing operations are located at various CMOs in Europe and the UK. As all manufacturing activities are outsourced, the Xbrane quality and supply chain teams are together with our partner STADA responsible for the quality oversight of the CMOs. Xbrane intends to independently manage CMO quality oversight and release of biosimilar medicinal products to the European market in 2024, taking over this responsibility from our partner STADA, why qualification and experience as QP is required for this role.
The role includes responsibilities such as:
• Lead the development and improvement of the Xbrane quality system (QMS) and coordinate and contribute as an expert in the upcoming submission for a manufacturing license to Swedish MPA
• Ensure, together with Xbrane team and management, that the QMS complies with regulations and requirements from authorities
• Facilitate company compliance through internal inspections and related improvements
• Together with the quality team represent the company in customer and authority inspections
• Ensuring that partners and contract organizations are in compliance with their quality systems and the quality agreements.
• Quality expert support in complex deviation management and CAPA
• Participating in general quality work and various projects
Your Profile
To succeed in this role, you are confident and knowledgeable in GMP, are a natural leader and enjoy collaborations both internally and externally and have a humble but confident mindset. You are used to working in projects and have a coaching approach to educating and ensuring quality compliance in the organization
In addition, you need the following qualifications:
• Minimum Bachelor's degree in natural sciences, such as Pharmacy, Microbiology, Biotechnology, Chemistry, Biology, Engineering, or a similar field
• Several years of work experience in the pharma industry , including experience in Biologics
• Fulfills the requirements for QP, LVFS 2004:7
• Qualification and experience of working as QP
• Very good knowledge of GMP and its application
• Preferably fluent in Swedish and English, as both documentations and meetings occur in both languages.
Interested?
Don't hesitate to contact us or submit your application. In this recruitment process, Xbrane is collaborating with Mpya Sci & Tech. Please submit your application no later than 11th of August. If you have any questions regarding the position or the recruitment process, you are welcome to contact Talent Advisors, Emelie Gralberg
emelie.gralberg@mpyascitech.com 0728886705 or Ellinor Crafoord
ellinor.crafoord@mpyascitech.com, 0721765167.
About Xbrane Biopharma
Xbrane offers an opportunity to work in a highly competent team. If you have a can-do attitude and on top of that share our values; Make it happen, Beat yesterday, Impossible is nothing and We win as one, you will prosper with us.
Xbrane Biopharma is a Swedish biotechnology company which develops and manufactures biosimilars. Xbrane has a patented protein production platform and world-leading expertise within biosimilar development. This is a company with an entrepreneurial spirit that focuses on being creative and coming up with new ideas as well as on following a rigorous process to bring those ideas to fruition. Xbrane's headquarter is located at Solna Campus, just outside of Stockholm, for more information see
www.xbrane.com. Ersättning Enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2023-08-11
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Mpya Sci & Tech AB (org.nr 559210-7204)
Arbetsplats Mpya Sci & Tech
Jobbnummer 7956877
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