Sweden Biologics QC Microbiology Manager
AstraZeneca Södertälje / Läkarjobb / Södertälje
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hela Sverige 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 Södertälje/Gärtuna Site in Sweden.
The role
The QC Microbiology Manager is responsible for the leadership of the Microbiology area within the Quality Control department and laboratories within the Sweden Biologics QC Laboratories. They are accountable for delivery of all activities in their area and development of a capable, motivated, informed effective and efficient workforce. The Manager will provide microbiological operational and scientific guidance and oversight to the Manufacturing Team.
Accountabilities/Responsibilities
To lead the Quality Control Microbiology laboratories, providing operational quality support within Sweden Biologics Operations and Outside Testing Laboratories (OTLs) as appropriate and ensure compliance with cGMP at all times.
To ensure via planning, delegation and resource management the timely, effective and compliant output of the laboratories to meet customer (schedule adherence) and regulatory requirements (licence to operate).
Provides scientific and operational oversight, contributing to policy.
Assist in the preparation of regulatory submissions and take the lead for their area in regulatory audits.
Development of a capable, motivated, informed and efficient workforce through coaching, development and training and other initiatives, including supporting on-site training needs.
The provision of resource and technical support to assist in method development / technical transfer and to actively encourage continuous improvement in working practices and procedures.
Oversees the Evaluation and Introduction of new technology/systems into the Quality Control Function ensuring that the Quality Control function remains contemporary and competitive.
Minimum experience
Qualified to degree level/or equivalent in a relevant scientific discipline.
Demonstrate understanding of Microbiological laboratory regulatory issues, especially environmental monitoring for sterile product aspects and sterility testing.
Sound knowledge and understanding of the principles and concepts of compliance management and Good Manufacturing Practice / Good Laboratory
Demonstrated knowledge of cGMP as defined by 21CFR and EU Regulations.
Budgetary and resource management planning experience
Managing complexity (Ambiguity and Conflicting priorities)
Effective problem and conflict resolution skills and proven team focus
Preferred experience/requirements
Familiarity and experience using relevant enterprise Quality Control Systems e.g. LIMS
More information
Welcome with your application no later than 31 August 2016.
For more information please contact Mike Austin +447803141551.
FOR FULL JOB DESCRIPTION AND TO APPLY, please visit
www.astrazeneca.se/karriarVaraktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2016-07-11ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2016-08-31
Ange följande referens när du ansöker: SOD000002HN
FöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Västra Mälarhamnen 9
15185 Södertälje
Övriga kontaktuppgifterTelefonnummer: 08-553 260 00
Jobbnummer 2949581
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