Stability Program Manager - Have you been working with LIMS?

Have you been working in Quality Assurance or Quality Control with LIMS? Are you looking for an opportunity to learn and grow? We're looking for a Stability Program Manager to bring fresh ideas to the table.



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.



Welcome to AstraZeneca's "production heart" in Södertälje, one of the world's largest manufacturing units for pharmaceuticals. Here, we thrive in a high-tech and LEAN-based environment where we value collaboration, continuous improvement work and smart solutions highly. Our two sites are beautifully situated close to urban environments as well as the waterfront and forests. Why not start the day with a spinning class, relax with mindfulness at lunch or wrap up the day singing in our AstraZeneca choir? Tag along!



Our organization, 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.



Today we´re 8 Stability Program Managers looking forward to meet our new colleague! We enjoy each other´s company and make sure we're having fun at work with a lot of laughs.



What you'll do

The Stability Programme Manager (SPM) is responsible for ensuring 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.



Essential Requirements

* Educated to BSc level, fluent in Swedish and English
* Thorough knowledge of cGMP requirements and their applicability to Operations and Quality
* Experience working in GQC LIMS or equivalent system
* Strong communication skills and ability to build effective relationships with team and customers
* Excellent team working skills
* A solution based approach



Desirable Requirements

* Experience in Operations, Quality 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



Why AstraZeneca? Our offer to you.



When we at AstraZeneca see the chance to change, we take this opportunity - every opportunity, no matter how small, can be the beginning of something big. Delivering medicine that changes people's lives is about having an entrepreneurial spirit - finding moments and understanding its potential.



We are looking for you, who together with your team will make a difference for patients' lives every day. This through your ability to independently lead and motivate your team to achieve set goals within budget, time and to the right quality. AstraZeneca welcomes your positive attitude and your desire to develop both yourself, your team and the department. You will get use for your drive and your ability to work diligently and structured even at a high tempo.



If you're looking for more info on our more tangible benefits, such as vacation days and bonus - look no further, its here --> http://bit.ly/AstraZenecaBenefits



Are you already imagining yourself joining our team in Södertälje? Good, because we can't wait to hear from you.



For more information about the positions please contact: EvaBäckman at +46 8 552 52230



Welcome with your application no later than 10th of May 2020. We will review and interview continuously as applications come in, so don't hesitate - apply now!