Sweden Biologics Validation Manager
AstraZeneca Södertälje / Chefsjobb / 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 Validation Manager is responsible for the Validation Processes at the Sweden Biologics Facility. They are the subject matter expert and represent the site for validation activities. They are a leader in process and validation improvements and initiatives and responsible for the management of validation budget and appropriate resources .
Accountabilities/Responsibilities
Subject matter expert in validation regulatory guidelines and procedures for sterile biopharmaceutical manufacturing, including representing Validation during regulatory inspections.
Develop and manage the validation strategy for the Sweden Biologics Facility
Dealing with complexity (Ambiguity and Conflicting priorities) - exercising good risk based judgement associated with the change management process.
Work collaboratively with Sweden Operations partners to ensure effective use of knowledge and resources.
Direct day to day operations of manufacturing, facility, computer, and cleaning validation services
Program manager for multiple validation projects
Technical expert for process improvements, investigations and troubleshooting
Prepare, coordinate execution, review, and approve in-depth process validation protocols and reports (computer, facilities, process, and cleaning)
Minimum experience
Substantial knowledge of cGMP, in particular Biologics manufacturing and/or laboratory practices, with Aseptic experience.
Good knowledge of production equipment, facilities, engineering and instrumentation
Knowledge of engineering terminology and requirements in regards to equipment together with strong technical report writing skills and excellent communication skills
Provide technical training and underpinning knowledge training to manufacturing department to improve process and analytical knowledge, and understanding of the manufacturing operators
Knowledge of ICH guidelines and experience in analytical validation
Effective problem and conflict resolution skills and proven team focus
Preferred experience/requirements
Familiar and experienced with relevant enterprise knowledge systems e.g. Discoverant
More information
Welcome with your application no later than 31 August 2016.
For more information please contact Mike Austin +447803141551.
FOR FULL JOB DESCRIPTION ADN TO APPLY; please visit
www.astrazeneca.se/karriar .
Varaktighet, 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: SOD000002HO
FöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Västra Mälarhamnen 9
15185 Södertälje
Övriga kontaktuppgifterTelefonnummer: 08-553 260 00
Jobbnummer 2949890
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