Quality Control Specialist Microbiology to AstraZeneca
Poolia Sverige AB / Kemiingenjörsjobb / Stockholm
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hela Sverige Visa alla jobb hos Poolia Sverige AB i Stockholm,
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hela Sverige We are looking for specialists within microbiology for a consultant assignment as a subject matter expert at Sweden Biologics in Södertälje.
Do you have experience of Quality Control and Microbiology, do you like to lead projects within a pharmaceutical setting? Do you want to use your expertise in a company that follows the science and turns ideas into life changing medicines for patients? Then Sweden Biologics might be interesting for you! Please, don't hesitate and submit your application today!
Let us introduce you to AstraZeneca:
At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make lifechanging medicines a reality.
Description of Sweden Biologics:
Welcome to the start-up of AstraZeneca's new Biologics factory in Södertälje, a central part of AstraZeneca's strategy to the manufacturing of Biological drugs. Here, we thrive in a high-tech and start-up-based environment where we value collaboration, entrepreneurialism and smart solutions.
The purpose-built facility will fill and pack the next generation of clinical and commercial biological drugs from the AstraZeneca pipeline; supporting the acceleration of the Biologics portfolio.
Sweden Biologics Quality Control:
At Sweden Biologics Quality control (QC) department is divided in to three functional groups, Bioassay, Biochemistry and Microbiology. Each group consists of approximately 6-8 persons. At the department QC immunologists, QC analytical biochemists, QC microbiologists work alongside QC specialists and QC information system specialists. All staff collaborate closely on general QC responsibilities whilst achieving group specific deliverables.
In order to further support the QC department, we are now recruiting an additional QC specialist. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Main Duties and Responsibilities:
Your main duties will be to work with microbiological laboratory methods and systems, in accordance with the appropriate cGXP, and to support the QC department in order to produce reliable and precise data to support product release.
Your responsibilities will also include to work cross functionally within the site organization and the broader AstraZeneca network in order to close daily deliverables and more long-term projects commitments to enable the site to be fully operational.
• You will act as a subject matter expert in the Microbiological discipline, Product testing, including sterility testing, and aseptic aspects
• Provide expert technical knowledge and give support to the broader Quality Control function and to the site
• Be involved in writing, review and approval of SOPs and other relevant GMP and validation documents and reports
• To lead prioritized projects to establish the functionality of this new facility, e.g. the introduction of sterility testing isolators and electronic systems to track and trend environmental sampling results
• Delivering training and coaching to the staff within the group and within the site
• Be instrumental in functional and cross functional investigations
• Respond effectively to technical requests from the Quality Control function using expert knowledge of Quality Control instrumentation and methodology
• Lead problem solving sessions including root cause investigations to minimize down-time and drive efficiency
• Represent QC in GMP inspections
• Lead smaller, local projects
Requirements
• Master's Degree or equivalent in microbiology or a related discipline
• Language level: Fluent in both writing and speaking Swedish and English
• Extensive experience in Good Manufacturing Practice (GMP) environment / Good Laboratory Practice (GLP)
• Good understanding of Quality Control testing techniques, aseptic manufacturing process and validation processes
• Previous Pharmaceutical Industry experience for at least 5 years.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2019-11-06ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-11-13
Klicka på denna länk för att göra din ansökanFöretagPoolia Sverige AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "55176".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Arbetsplats Poolia Life Science & Engineering AB
Jobbnummer 4942920
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