Stability Programme Manager

Presentation
We are currently looking for a consultant for a temporary assignment as a Stability Programme Manager (SPM), at AstraZeneca, Södertälje, Sweden. The Global Stability group, within Operations Quality at AstraZeneca, is responsible for the overall coordination and quality assurance of the Global Commercial Stability Programme, providing continuous assurance that AstraZeneca products remain at the highest level of Quality throughout the shelf life. 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. The assignment which is full-time will start in August 2017, and continue until the end of December 2017. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible.


Arbetsuppgifter
The Stability Programme Manager is responsible for ensuring compliance with AstraZeneca´s commercial stability obligations by generation, provision and maintenance of the Global Commercial Stability Programme.

· Generation and maintenance of the Stability Master Plans and the supporting stability test protocol information.
· Ensure the global Stability Programme 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.

The roles demand thorough understanding of pharmaceutical stability testing and a full overview of Operations activities and how this contributes to achieving the objectives of the business. The job holders have effective levels of interactive communication with stakeholders and project team members directly advising and influencing them.


Utbildning/erfarenhet
Minimum Requirements - Education and Experience

- 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

Desirable Requirements

- Experience in Operations and/or R&D
- Strong knowledge of and background in Quality Systems, e.g. stability management, QC or QA
- Able to demonstrate the drive and energy to establish the role and make a difference


Förmåner
We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.

As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.

Företagsbeskrivning
Poolia Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world’s leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

Sluttext
Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail adress is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.

Language
en-GB