Stability Quality Assurance Manager, Global Quality
AstraZeneca AB / Kemistjobb / Södertälje
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hela Sverige Would you like to apply your expertise to impact the quality performance strategy in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be of interest to you!
At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
The Global Stability Team sits within Operations Corporate Quality & Strategy. The team manages the Global Stability Strategy and provides stability expertise for technical issues. The group designs and manages an optimised global stability programme to monitor and ensure the quality of our products throughout their shelf life. The team acts globally and support all product licenses in all markets.
The group operates in the interface between the operation sites, stability testing sites and the regulatory function. It has prime accountability for proactive and focused support on all aspects of stability management for all global operations sites. The team has a regulatory and technical focus. Today we're 9 SQAM located in Sweden and we're looking forward to welcoming our 10th member!
Main Duties and Responsibilities
As a Stability Quality Assurance Manager, you will join our dedicated Global Stability Management team and we will look to you to demonstrate your quality assurance as well as technical expertise to support our new and established products.
You will be responsible for assuring that a commercial product portfolio is managed in compliance with AstraZeneca's commercial stability obligations. You will use your expertise to analyze stability information and data to support license management for global products. You will also need skills to influence stakeholders and project team members.
Your role will involve the strategic and technical assessment of supply chain changes, process and packaging changes, and translating findings into the appropriate programs of stability studies.
The Stability Quality Assurance Manager will be responsible for overall surveillance of data, stability profiles and issues arising from the global commercial stability program. Driving investigations that will involve multiple functions from the supply chain of affected products and assure the integrity of stability study reports intended for submission to regulatory agencies. You will also be required to identify issues that may lead to non-compliance with GMP, regulatory requirements and commitments, and advise on areas for improvement across Global Stability Management.
Essential Requirements
* Educated to Degree or Equivalent experience in a science discipline
* Experience in Regulatory, QA/QC or pharmaceutical development in a Pharmaceutical or related Industry
* Strong data handling skills and an understanding of the importance of data integrity
To truly thrive in this role you need to have a well-developed ability to analyze qualitative and quantitative stability information. This in order to draw conclusions and make recommendations, based on clear scientific rationale.
Desirable Requirements
You know how to engage and motivate others. You also enjoy working in a team and to develop your network within the business.
Are you ready to bring new ideas and fresh thinking to the table? Great! We have one seat available and we hope it's yours.
For more information about the position please contact Sabina Erhardsson on 08-55322815.
Welcome with your application no later than November 17th 2019.
In an effort to diversify our workforce, as we are a majority of women we especially encourage other applicants.
AstraZeneca is acting as an Employment Agency in relation to this vacancy.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-11-04ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-11-18
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-065020".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 4939303
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