Quality Control Specialist Microbiology.

Details

Contact:
Melina Arcos, 
+46733434337, 
melina.arcos@randstad.se
Application deadline:
2019-11-15
Job type:
full time
Type of employment:
Permanent
City:
Stockholms län, 
Södertälje kommun
Category:
Life Science
Position:
Läkemedel, bioteknik & medicinteknik

Job description.

Do you have experience of Quality Control and Microbiology, do you like to lead projects within a pharmaceutical setting?  We are currently looking for candidates for a consultant assignment as Quality Control Specialist Microbiology at AstraZeneca's new biologics manufacturing plant at Gärtuna, Södertälje.

Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!

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.

responsibilities.

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

qualifications.

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.

application.

Deadline for application is 2019-11-15, and selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.
 
 For more information: Melina Arcos, melina.arcos@randstad.se 

about AstraZeneca AB.

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https://www.astrazeneca.se