Risk Management Leader
Poolia Göteborg AB / Kemiingenjörsjobb / Göteborg
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hela Sverige AstraZeneca is now looking to recruit for a 12 months consulting assignment a Risk Management Leader within the area of Inhalation Product Development and Device & Packaging. 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. 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 Risk Management Leader 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 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
Who you are
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
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: 48865
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 3869478
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