Quality Engineer
Poolia Göteborg AB / Kemiingenjörsjobb / Göteborg
2017-12-21
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hela Sverige AstraZeneca is now looking to recruit for a 12 months consulting assignment a Quality Engineer within the area of Inhalation Product Development and Device & Packaging. As Quality Engineer you will be a key of a cross functional development for the development of an inhaler. You will ensure that the projects are delivered with the highest quality and compliant to requirements from Health Authorities, Regulations and Standards. You will be responsible to ensure that the right processes, procedures and best practices are executed and implemented in the projects. The consulting assignment will start 2018-01-22 and go on to 2019-01-22. Are you the one we are looking for? Next step, apply today - the recruitment process is already ongoing and interviews will be held continuously.
about the consultant assignment
The arena:
AstraZeneca has a long-standing reputation as being a leader in advanced Drug Delivery products. At the beginning of 2016, Pharmaceutical Technology and Development (PT&D) became an integral part of Global Operations. A global organization with 1,100+ workforce disbursed across UK, Sweden, Germany, US and China, with additional colleagues located at key manufacturing sites. We support launched and development portfolios.
With innovation at the center of everything we do, we design and deliver the active drug product (including formulations, devices and packaging) required to support new medicines - from products to be used in toxicology studies and clinical trials to development of the technology to ensure that drug products can be scaled up for manufacturing on a commercial scale.
Inhalation Product Development (IPD) Device & Packaging Gothenburg is a team within Pharmaceutical Technology and Development (PT&D) and our team focuses on designing and developing devices for inhalation drug administration and packaging of pharmaceuticals and devices. We are looking for an experienced Quality Engineer to be part of the development team for one of our inhalation device projects. The job holder will be part of a Design core team, who will work closely with other core team engineering leaders; e.g. Design, Test, Quality, Human Factors, etc.
The role:
As Quality Engineer you will be a key of a cross functional development for the development of an inhaler. You will ensure that the projects are delivered with the highest quality and compliant to requirements from Health Authorities, Regulations and Standards. You will be responsible to ensure that the right processes, procedures and best practices are executed and implemented in the projects.
Activities typically includes, but limited to:
• Work proactively with development team to plan, develop, and deliver medical devices and combination products that are of the highest quality and also satisfies user needs.
• Ensure project team follow processes, procedures, ways of working and templates
• Ensure the project is compliant to applicable regulations, laws and standards
• Facilitate risk assessment events and ensure that risks process is executed
• Provide expert knowledge to the project team when it comes to GXP ways of working
• Ensure documentation are written a quality and regulatory way
• Be a link between the QA, Medical Device Regulatory Affairs and the project team
• Work with other Quality Engineer to drive harmonization across project and execute quality engineering initiatives
• Author DHF index and Essential Requirements List
• Ensure high quality and compliant DHF by review project team documentation
Who you are
Minimum requirements:
• 5+ years' experience working in development of medical devices or other relevant regulated industry
• 3+ years ' experience working in a Medical Device Quality or Regulatory department
• Extensive understanding of process for development of Medical Devices and Combination Products; MDD, ISO 13485, FDA 21 CFR 820 and FDA 21 CFR 4
• Experience in establishing DHFs, Technical Files and Dossiers
• Good understanding for medical device technical standards; ISO, IEC FDA guidelines
• Excellent organizational and communication (oral and written) skills.
• Ability to work on teams as well as individually
• Ability to be pragmatic but still be compliant to solve problems
• Good leadership and interpersonal skills
• Good technical and regulatory writing skills
• Fluent in English
About Poolia Life Science & AstraZeneca
Poolia Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden's leading pharmaceutical and life science companies. So whether you're interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.
Next step, apply today!
Varaktighet, arbetstid
Heltid Sex månader eller mera
Publiceringsdatum2017-12-21ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-01-05
Ange följande referens när du ansöker: 48864
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 3869404
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