Stability Quality Assurance Manager (sqam)
AstraZeneca Göteborg / Kemiingenjörsjobb / Södertälje
Observera att sista ansökningsdag har passerat.
Visa alla kemiingenjörsjobb i Södertälje,
Salem,
Ekerö,
Nykvarn,
Botkyrka eller i
hela Sverige Visa alla jobb hos AstraZeneca Göteborg i Södertälje,
Göteborg,
Mölndal eller i
hela Sverige At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
At AstraZeneca, innovation is about more than just research. We aim to stimulate continued creativity throughout our organisation by maintaining a culture in which our people feel valued, energised and rewarded for their ideas and contribution to our success - ideas which can make a difference in all aspects of our business.
An exciting opportunity has arisen to join Global Technical Services - Stability within Operations Quality, based in Sodertalje, Sweden.
The Global Stability Team sits within Operations Quality. The team manages the Global Stability Strategy, Quality Assurance aspects of commercial stability programmes 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 shelf life. The activities of the team support 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.
The role
As a Stability Quality Assurance Manager, you will join our dedicated Global Stability Management team and we will look to you to demonstrate your technical expertise to support on 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 analyse 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 programmes of stability studies
You 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
• Typically educated to Degree or Equivalent in a science discipline
• Experience in Regulatory, QA and /or QC within a Pharmaceutical or related Industry
• An ability to analyse qualitative and quantitative stability information to draw conclusions and make recommendations, based on clear scientific rationale
• Strong data handling skills and an understanding of the importance of data integrity
• An ability to recognise and react to different perspectives, and negotiate to reach positive outcomes
• Strong communication skills and ability to build effective relationships with team and customers
• Excellent team working skills
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.
If you are interested, apply now!
For more information about the positions please contact:
Susanna Gilled at +46 8 552 518 93 or Nina Tasala at +46 8 552 511 73.
More than ever, science is accelerating our rate of understanding in a wide range of medical fields - and that's only set to increase. As a global, science-led biopharmaceutical business, AstraZeneca is at the forefront of that evolution. That means an unparalleled product portfolio and a strong pipeline across all stages of the drug development process. Everything we do comes back to improving the health of our patients worldwide, and to make that happen we're focusing on some of the most challenging diseases facing humanity today.
We have a highly collaborative culture, where you'll be encouraged to push the boundaries of science while developing industry-recognised skills and experiences.
Publiceringsdatum2017-05-04Så ansöker duSista dag att ansöka är 2017-05-21
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Göteborg
AdressAstraZeneca Göteborg
Karlebyhus, Astraallén
15185 Södertälje
KontorsadressKarlebyhus, Astraallén
Jobbnummer 3476778
Observera att sista ansökningsdag har passerat.