Senior Stability Expert - Global Stability Management
AstraZeneca / Kemistjobb / Södertälje
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The Global Stability group, within Operations Quality at AstraZeneca, is responsible for the design, overall coordination and quality assurance of the global Commercial Stability Programme. This involves developing Stability strategies that meet the product lifecycle requirements, dealing with related issues and providing quality oversight to the manufacturing units and Health Authorities.
As a Senior Stability Expert in Södertälje, you will be a recognized expert across Operations on Stability related matters, ensuring compliance with AstraZeneca's commercial stability obligations, through having the oversight of regulations, product lifecycle and strategies, and stability quality profile knowledge.
Main Duties and Responsibilities
As part of the Stability Leadership team, reporting to the Global Stability Director, it'll be your job to ensure that all of AstraZeneca's commercial stability obligations are adhered to, both within the function and through working with stakeholders and customers.
You will be actively enabling the global Commercial Stability Programme and challenging the current ways of working when appropriate, in order to ensure best practice and efficiency.
Example of responsibilities below;
* Build and maintain expertise in all aspects of stability management and maintain awareness of changing regulatory requirements and provide an 'internal consultancy' role to AZ.
* Act as an expert and coach for the members of the Global Stability Management to ensure the appropriate stability strategies are in place to support product on market & licence to operate.
* Build effective networks across the global Operations organisation, Pharmaceutical Development and Regulatory Affairs.
* Interpret changing Regulatory requirements and assess the impact on the AZ processes and standards, including cross functional discussions and development of AZ stability related positions.
* Support external and internal regulatory inspections for all aspects of Stability management.
Minimum Requirements - Education and Experience
* BSc level in Chemistry or Pharmacy or Chemical Engineering
* Excellent written and verbal Swedish and English
* Thorough knowledge of cGMP requirements and applicability to manufacturing, distribution, and analytical testing
* In depth understanding in the disciplines in Analytical Science, Formulation and global supply chain
* Lean Leadership including successful adoption of lean tools such as visual management and problem solving
* A minimum of 12 months experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance
Desirable Requirements
* Background in stability management through experience gained in Operations QA, analytical chemistry or R&D.
Skills and Capabilities
* Excellent team working, communication and networking skills
* Ability to coach, without direct management responsibility
* High level of understanding of change management
* Good ability to influence at all levels and across cultural interfaces
* Take a Strategic perspective, and be able to plan and set the right objectives to deliver results over the medium to long term.
* Ability to work with short and/ or changing timelines demonstrating effective prioritisation and clarity
* Ability to make effective decisions despite uncertainty and/or incomplete information to drive business outcomes
So, are you ready to be part of a dynamic team supporting the global stability programme for all AstraZeneca's products? Apply now!
Include both a resume and a cover letter in your application. In your cover letter, please describe what in your background makes you a good candidate for this position!
For more information about the position please contact Eleonor Alfredsson +46 (0)730938528
Welcome with your application no later than 5th May 2019
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-04-16ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-05-05
Ange följande referens när du ansöker: R-049197
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
karin.serden@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
15185
15185 0181
KontorsadressAstraallén
Jobbnummer 4736715
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