Stability Program Manager, AstraZeneca
Modis Sweden AB / Läkarjobb / Stockholm
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hela Sverige MODIS Life Science is looking for a Stability Program Manager (SPM) to AstraZeneca!
The consultant assignment will start on August 1st and proceed until the end of the year, but with very good chances to prolongation.
Welcome with your application no later than June 6th.
Om AstraZeneca
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. But we 're more than one of the world 's leading pharmaceutical companies. At AstraZeneca, we 're proud to have a unique workplace culture that inspires innovation and collaboration.
The arena
Global Stability Management (GSM) is a Central Quality Operations group, responsible for the technical support of all established, small molecule products and major brands developed in AZ, including the responsibility for the management of the AZ global stability program and all the associated activities.
GSM is responsible for the Management of the commercial stability Program and Quality system which supports all AstraZeneca 's small molecule Drug Substances and Drug Products. GSM has prime accountability for proactive and focused support on all aspects of stability management for all global Operations sites and CMOs. The group has a technical, scientific and regulatory skill set.
The role
The SPM is responsible for ensuring by generation, provision and maintenance of the Global Commercial Stability Program.
• Generation and maintenance of the Stability Master Plans and the supporting stability test protocol information
• Ensure the global stability program fulfils all regulatory requirements, and is optimized and effective.
• Communication of the Stability Master Plans to the Stability QC Centres.
• Translation of stability sections in CMC documentation and Commitments into the Stability Master Plan.
• Assure the provision of accurate, submission ready stability data information that is in compliance with market specific Health Authority.
• Identification of any issues that may result in stability related non-compliance with GMP, regulatory requirements or commitments.
• Maintenance and update of storage life records within S-Life.
Profile
• Educated to BSc level, fluent in Swedish and English
• Thorough knowledge of cGMP requirements and their applicability to Operations and Quality.
• Strong communication skills and ability to build effective relationships with team and customers.
• Excellent team working skills
• A solution based approach
Preferred experience/requirements
• Experience in Operations and/or R&D
• Strong knowledge of and background in Quality systems eg stability management, QC or QA
• Able to demonstrate the drive and energy to establish the role and make a difference.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is placed.
About Modis
We are constantly striving to support our customers and consultants to become successful. As a consultant, you are our top priority and when you need us, we will be there for you.
We will include you in our business and to our customers. You are our most important asset and for us to stay ahead you will take an active part in our business development and our offers to the market.
By becoming our colleague, your daily life as a consultant will be shifting with different assignments and projects in a variety of industries, systems and environments. Your experience will increase as well as your social and professional network. As a consultant, you are covered by collective agreements, insurance, occupational healthcare, healthcare and discounts on training cards. We believe in connecting people so having regularly social activities is key for us.
Modis delivers a wide range of services and competencies within IT, Engineering and Life Science. Our services are characterized by speed, simplicity and quality. Modis is represented in the United States, Canada, Europe with over 100 offices and with more than 35,000 colleagues on assignments each day.
If you have questions regarding the position, please contact:
Nalin Yilmaz
E-postadress:
nalin.yilmaz@modis.seTelefon: 073 6847 051
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2018-05-28ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-06-08
Klicka på denna länk för att göra din ansökanKontaktNalin Yilmaz
Nalin.Yilmaz@modis.seFöretagModis Sweden AB
AdressModis Sweden AB
Postgatan 28
41110 Göteborg
KontorsadressPostgatan 28
Jobbnummer 4168853
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