Quality Engineer to AstraZeneca in Gothenburg
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige ALTEN Pharma is looking for a competent and driven Quality Engineer for a consultancy assignment to AstraZeneca in Gothenburg.
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
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 ALTEN
FOR OVER 20 YEARS, ALTEN HAS DEVELOPED ITS BUSINESS BY KEEPING TO THE CORE VALUES ??THAT HAVE BUILT UP THE COMPANY'S SUCCESS. EVERY YEAR, HUNDREDS OF ALTEN CONSULTANTS HAVE BEEN GIVEN THE OPPORTUNITY TO EMBARK ON CHALLENGING TECHNICAL PROJECTS FOR OUR CUSTOMERS. ALTEN HAS A TRADITION OF DEVELOPING PRODUCTS IN MANY AREAS, AND HISTORY IN SWEDEN IS BASED PRIMARILY ON SKILLS IN MECHANICS, SOFTWARE AND ELECTRONICS. THANKS TO A SUCCESSFUL CONCEPT IN WHICH WE UTILIZE THE EXPERTISE OF EXPERIENCED CONSULTANTS AND DEVELOP YOUNG ABILITIES TOWARDS A SUCCESSFUL CAREER, WE HAVE GAINED GROUND IN MANY INDUSTRIES. OUR PHARMA INITIATIVE IS BASED ON THE SAME SUCCESSFUL CONCEPT WITH THE SAME STRONG STRUCTURE, BUT IN A NEW EXCITING INDUSTRY AND A NEW FIELD OF EXPERTISE THAT INCLUDES KNOWLEDGE IN CHEMISTRY, BIOTECHNOLOGY AND BIOMEDICINE.
AS AN EMPLOYEE AT ALTEN, WE OFFER YOU A COMPETITIVE SALARY BASED ON YOUR PERFORMANCE AND WORK EXPERIENCE. YOU ALSO HAVE THE OPPORTUNITY TO INFLUENCE YOUR ASSIGNMENTS, DIFFERENT BENEFITS AND YOUR OVERALL WORKING ENVIRONMENT AS WELL AS CHOOSE YOUR CAREER PATH. WE OFFER A WIDE RANGE OF INTERNAL TRAININGS AND AN OPPORTUNITY TO PLAN FOR AN INTERNATIONAL CAREER. IT IS OUR CONVICTION THAT GENUINE COMMITMENT IS CREATED THROUGH CHOICE AND THE ABILITY TO INFLUENCE YOUR OWN PERSONAL DEVELOPMENT - OUR BUSINESS MODEL PROVIDES THAT OPPORTUNITY. THIS FREEDOM OF CHOICE ENABLES US TO OFFER OUR CLIENTS THE MOST COMMITTED CONSULTANTS, REGARDLESS OF ASSIGNMENTS. AT ALTEN, WE BELIEVE IN GROWING TOGETHER!
For questions about ALTEN or the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-05-24ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-05-30
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4163208
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