QC-specialist i Mikrobiologi
MODIS Life Science is now looking for a QC-specialist for a consultancy assignment at AstraZeneca in Södertälje. This opening is for initially 6 months. As a consultant you will be hired by MODIS and work on an assignment at our customer. If you find the described assignment interesting send your application.
About the customer:
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!
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.
About the role:
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
• 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.
Please submit your application by attaching your CV and personal letter in English (interviews are held continuously).
If you have any questions about the assignment, do not hesitate and contact Cecilia Larzon (email@example.com).
Modis is a staffing & recruiting company and is part of the Adecco Group, the world´s leading HR-solutions provider across 60 countries. This scale and scope ensures Modis is truly a global community. Our mission is to be the Leading Professional Services Company by finding the right match between you as a candidate and you as a customer. We are a team with various and complementary backgrounds within Life Science, Engineering and Technology. We can ensure that we understand our customer needs and we can ensure that we understand the competence-profiles of our applicants and candidates.
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