Stability Program Manager to AstraZeneca - Poolia Stockholm AB - Kemistjobb i Södertälje
Stability Program Manager to AstraZeneca
Poolia Stockholm AB / Kemistjobb / Södertälje
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Do you have thorough knowledge of cGMP? Do you have a background in Quality systems eg stability management, QC or QA? AstraZeneca is now looking to hire a Stability Program Manager (SPM) for a consultant assignment. The assignment is planned to start 1:st of August.
Please send in your application today as we are interviewing candidates continuously.

Poolia is offering permanent employment and fixed monthly salary.

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.

* 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.
* Collective agreement with Unionen (
* Strong benefits/offers designed for your need
* Individual career support
* Encouraging life career
* Broad professional network
* Committed consultant manager

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Sista dag att ansöka är 2018-06-04
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Poolia Stockholm AB

Poolia Stockholm AB
Kungsgatan 57 A
10124 Stockholm

Kungsgatan 57 A


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