Stability Quality Assurance Manager to AstraZeneca
Modis Sweden AB / Läkarjobb / Södertälje
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hela Sverige MODIS Life Science is looking for a Stability Quality Assurance Manager to AstraZeneca, Södertälje!
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!
About 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 SQAM has responsibility for a Commercial product portfolio. The job holder is responsible for Stability Quality Assurance, in relation to all aspects of the global commercial stability management and will evaluate stability information to support license management for global commercial products.
Overall surveillance of data, global product stability profiles and issues arising from the global commercial stability program by evaluation and trending across all stability information:
• Technical assessment of impact of; supply chain changes, process and packaging changes, and translation of these into appropriate programs of stability studies.
• Assurance of the integrity of stability study reports intended for submission to regulatory agencies, including; selection of studies; scientific rational used in discussions/conclusions; compliance with the regulations of the health authorities that will receive the report.
• Initiate/coordinate/participate in investigations
• Stability QA support for Operations sites, e.g. stability contribution to APR/PQR, Temperature Excursions, Health Authority inspections, Stability technical support.
• Commercial stability input to NPI projects and take over the stability QA responsibilities after handover from R&D.
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:
Anders Olsson
E-postadress:
anders.olsson@modis.seTelefon: 073 684 72 48
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 ansökanKontaktAnders Olsson Anders.Olsson@Modis.se
FöretagModis Sweden AB
AdressModis Sweden AB
Hamngatan 13
11146 Stockholm
KontorsadressHamngatan 13
Jobbnummer 4169418
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