Quality Assurance Manager

Arbetsbeskrivning

Looking for a new challenge? Join our Quality Assurance Team!
We are looking for a Quality Assurance Manager, with experience of transmission electron microscopy and project management.
As a QA manager you will be part of an experienced quality team and report to the Quality Director. We are located on modern premises with good commuting opportunities in central Stockholm.
Main tasks:
- QA approve deviations, CAPAs, changes, unexpected test results and complaints
- Participate in validation activities and QA approve validation documents for analytical methods, equipment, and computerized systems
- Write, review and QA approve standard operating procedures (SOPs) and other governing documents
- Maintain and continue to develop our quality system and work processes with the possibility to act as a project leader for cross-functional improvement projects
- Plan, take active part in, and report outcome of external audits and internal self-inspections
- Communicate with customers regarding e.g. quality agreements and questionnaires
- Evaluate and approve suppliers

What is needed:
You are analytical, structured, accurate and self-organized, and are expected to take initiatives and drive your work with high quality from start to finish. You have a customer-focused approach and a strong personal integrity in quality matters. You have a positive and improvement-oriented mindset and enjoy working in a highly dynamic environment. You have excellent communication and social skills with the ability to communicate, teach and enthuse. You have good team player abilities and are not afraid of helping out with tasks outside your normal responsibilities.
Necessary experience:
- MSc or higher, in chemistry, biology, medicine, pharmacy, engineering or similar
- Experience of quality work within the pharmaceutical industry, with strong drive toward improvements
- Practical experience of investigations and assessments of deviations, CAPAs, changes and risk management
- Practical experience of validation/qualification of equipment and computerized systems
- Experience and aptitude for project management
- Fluency in English; both spoken and in writing. Our company language is English.
- Theoretical and practical experience in performing the full process of negative stain electron microscopy and/or cryo electron microscopy
- Experience from the equipment and systems used, e.g., VAS and Centuri software, Transmission Electron Microscopes, such as Glacios, Talos
- Practical experience of external audits and internal self-inspections.
Founded in Stockholm in 2005, Vironova is a world leading partner to the global life science community in the development of novel therapies for tomorrow. By combining hardware and software solutions for advanced electron microscopy analysis, we support our partners through the whole value chain. From initial sample preparation to imaging and final analytical result, our dedicated team provide insightful and actionable data. We empower clients to make better-informed decisions, to create value and ensure safety for patients worldwide.

Interested? Send your application to hr@vironova.com. We will review applications continuously.

Sammanfattning

  • Arbetsplats: Vironova Bioanalytics AB Stockholm
  • 1 plats
  • Tills vidare
  • Heltid
  • Fast månads- vecko- eller timlön
  • Publicerat: 19 december 2022
  • Ansök senast: 3 januari 2023

Postadress

Gävlegatan 22
Stockholm, 11330

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