Sweden Biologics Devices

AstraZeneca Södertälje / Kemistjobb / Södertälje
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AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace 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.

We have an exciting opportunity for someone to join our new Biologics Protein Therapeutics Filling and Packaging facility based at the AZ Gartuna Site in Sweden.

The role

The Devices SME is accountable for ensuring that Sweden Biologics Facility?s License to Operate is maintained by managing the quality, manufacturability and supply chain for key devices which are used / supplied by the Sweden Biologics Facility

Accountabilities/Responsibilities

Ensure that the Sweden Biologics Facility has appropriate procedures, standards and guidance to address the regulatory and operational requirements of Device management
Ensure that projects and changes at the Sweden Biologics Facility or within the upstream devices supply chain are appropriately understood, controlled and adhere to the appropriate standards for devices
Responsible for ensuring consistent best practice for Device Management is used across the Sweden Biologics Facility, for example, Change Management, Technical training, Knowledge Management and Supplier Management.
Maintain a detailed understanding of the supply chain for devices and assess the capabilities and vulnerabilities
Understand the technical specifications that define the quality and manufacturability of device-related products at the Sweden Biologics Facility.
Provide technical expertise and manufacturing insight into the development of prototypes and concepts for new or significant changes to devices relevant to the Sweden Biologics Facility operations.
Minimum experience

To have a minimum of science degree or equivalent in Biochemistry or other science related field, or a degree in Biochemical or Chemical Engineering.
Good experience in the bio manufacturing industry is essential
A high degree of experience with cGMP production / sterile processes
Extensive experience of devices technology, standards and quality requirements
Good understanding of Regulatory and Commercial functions
Knowledge and experience of the AZ Risk Management (IRM) process

More information

Welcome with your application no later than 30 September 2016.

For more information please contact Mike Austin + 44 7803141551.

Varaktighet, arbetstid
Visstidsanställning 6 månader eller längre
Heltid

Publiceringsdatum
2016-08-18

Ersättning
Fast månads- vecko- eller timlön

Så ansöker du
Sista dag att ansöka är 2016-09-30
Ange följande referens när du ansöker: SOD000002IE

Företag
AstraZeneca Södertälje

Adress
AstraZeneca Södertälje
Karlebyhus, Astraallén
15185 Södertälje

Övriga kontaktuppgifter
Telefonnummer: 08-553 260 00

Jobbnummer
3001588

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