Stability Quality Assurance Manager to AstraZeneca

Poolia Stockholm AB / Kemistjobb / Södertälje
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Do you have thorough knowledge of cGMP requirements and their applicability to Operations and Quality? AstraZeneca is now looking to hire a Stability Quality Assurance Manager (SQAM) 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.

ABOUT THE CONSULTANT ASSIGNMENT
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 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.

WHO YOU ARE
• 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 POOLIA - WHAT'S IN IT FOR YOU?

• Collective agreement with Unionen (https://www.unionen.se/rad-och-stod/om-kollektivavtal)
• Strong benefits/offers designed for your need
• Individual career support
• Encouraging life career
• Broad professional network
• Committed consultant manager

Varaktighet, arbetstid
Heltid Tillsvidare

Publiceringsdatum
2018-05-28

Ersättning
Fast månads- vecko- eller timlön

Så ansöker du
Sista dag att ansöka är 2018-06-04
Ange följande referens när du ansöker: 50483
Klicka på denna länk för att göra din ansökan

Företag
Poolia Stockholm AB

Adress
Poolia Stockholm AB
Kungsgatan 57 A
10124 Stockholm

Kontorsadress
Kungsgatan 57 A

Jobbnummer
4169066

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