Senior Quality Assurance Manager
Vironova AB (Publ) / Organisationsutvecklarjobb / Stockholm
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hela Sverige Visa alla jobb hos Vironova AB (Publ) i Stockholm,
Solna eller i
hela Sverige Do you want to have the possibility to work with both quality and operational excellence? Join our Quality department!
As Senior Quality Assurance Manager you will have an important role in Vironova's further business and development journey and the continuous quality work of Vironova's services and products. You will be able to work with both long term strategic tasks and short-term operative tasks in a highly dynamic environment. You will be able to work with both quality and operational excellence with continuous improvements.
You will:
• Work both strategically and operatively with different tasks within our quality system and our processes for delivering high quality services and products
• Actively work to ensure that Vironova 's operations meet the regulatory requirements and assess our compliance to applicable regulations
• Work to ensure that the operations within Vironova Imaging Solutions (VIS) meet the GMP requirements as an independent control laboratory
• Approve documents, validation activities, deviations, changes, unexpected test results and complaints
• Write, review and approve standard operating procedures (SOPs) and other governing documents
• Take active part in external audits and internal self-inspections
• Evaluate and approve suppliers
• Take an active part in the further building of our quality and improvement culture
• Contribute to the continuous monitoring of the business quality performance and being active in quality and management reviews
• Take part in our operational excellence work to continuously improve and learn with the possibility to act as a project leader for cross-functional improvement projects
What you need to be successful:
This is a senior role and we expect you to have extensive experience from quality and improvement work within pharmaceutical development
• Minimum Bachelor of Science in chemistry, biology, medicine, pharmacy, engineering or similar, preferably MSc or higher (PhD is meritorious)
• Long standing experience from Life Science, preferably within Pharmaceutical development or a production environment
• Deep knowledge of Analytical and/or Bioanalytical chemistry with practical experience of different analytical techniques
• Deep knowledge of the regulatory requirements in the pharmaceutical industry and documented training in "GxP"
• Practical experience of both external audits and internal self-inspections
• Practical experience of working with investigations and assessments of deviations, changes errands, CAPAs and risk management
• Experience of project management, operational excellence with LeanSigma methodology and/or quality management with ISO9001 is a merit
As a person you need to be analytical, structured, and accurate. You are expected to take initiatives and drive your projects with high quality from start to finish. You have a customer focused approach, strong personal integrity in quality matters and excellent communication and social skills. You have a positive and improvement-oriented mindset and enjoy working in a highly dynamic environment.
Interested? Do not hesitate to submit your application today. We will review applications on an ongoing basis.
Vironova AB was founded in 2005 as a result of interdisciplinary research at the Karolinska Institute in Stockholm, Sweden and is today a fast-growing company with around 100 employees including subsidiaries. We offer unique services for nanoparticle characterization together with our software solutions (VAS) for advanced electron microscopy image analysis, viral clearance studies in our own lab andatabletop TEM system (MiniTEM) which enables automated image acquisition and data analysis for Life Sciences applications (e.g. gene therapy).
The Quality department in Vironova is working with both quality and operational excellence. We are an independent function within the company that plays an important role for the quality of Vironova's services and products and we have the strategic responsibility for the quality system and the continuous improvement and development of it. We monitor the business performance of the company 's main processes on a continuous basis and coordinate reviews and follow ups. For Operational excellence and continuous improvement, we act as project leaders for cross-functional improvement projects of different kind. We use and teach LeanSigma tools for efficiency, visualization, process mapping, risk analysis, root cause analysis, change management etc. Our scope covers all parts of the company.
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2019-09-13ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2020-03-01
Klicka på denna länk för att göra din ansökanFöretagVironova AB (Publ)
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Vironova AB (Publ) (org.nr 556678-1463),
http://www.vironova.com Arbetsplats Vironova
Jobbnummer 4889507
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