Risk Management Leader
Dfind Science & Engineering AB / Smedsjobb / Göteborg
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We are looking for our next consultant who is an experienced Risk Management Leader to be part of the development team for the inhalation device projects at AstraZeneca.
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. 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 Risk Management Leader you will be a key member of a cross functional design core team for the development of an Inhaler. We are looking for a senior team member, who will take the overall responsibility for the risk management work in terms of leading and facilitating risk management activities, provide input to the design work via risk evaluations and develop a solid risk management file. The risk management work will be conducted in close collaboration with internal and external team members and partners.
Activities typically includes, but is not limited to:
• Planning of risk management work
• Lead Hazard assessment
• Lead and facilitate individual risk assessment activities
• Facilitate identification, implementation and effectiveness evaluation of risk mitigations
• Develop a risk management file according to ISO 14971 and internal procedures
Minimum requirements:
• 5+ years' experience from medical device industry
• Good understanding of process for development of Medical Devices, in particular ISO 13485 and FDA 21 CFR 820
• Extensive experience in risk management
• Good understanding of ISO 14971
• Good leadership and interpersonal skills
• Good communication and presentation skills
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2018-01-05. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Alma Zanqrelle
alma.zanqrelle@dfind.se or Eleonor Ehrman 0733-434109
Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the work second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2017-12-21ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-01-05
Ange följande referens när du ansöker: 201111944
Klicka på denna länk för att göra din ansökanKontaktalma.zanqrelle@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 3869421
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