Risk Management Leader
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige In Gothenburg, ALTENs Pharmateam is searching for a Risk Management Leader for a consultancy assignment 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. 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
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 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 the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
We wish you a Merry Christmas and A Happy New Year!
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2017-12-22ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-01-05
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
recruitment@alten.seFöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssonsgata 15
41755 Gothenburg
KontorsadressTheres Svenssonsgata 15, Göteborg
Jobbnummer 3871925
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