Quality Control Information Systems Specialist - AstraZeneca

Do you have expertise in and passion for Quality control information systems and would like to apply your expertise to impact the Quality control organization in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!



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 the impossible a reality. 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.



The Sweden Biomanufacturing Center (SBC) is a strategic investment to support the AstraZeneca biologic product portfolio, we shape the future by delivering advanced and sustainable biological drugs. The new Drug Product manufacturing facility have the capability to support the Astra Zeneca biologic commercial pipeline and biologic clinical trial and launch programs. We operate in a multicultural and global environment where revolutionary digital solutions propel us forward.



Do you want to go to a job that makes a difference for both its employees, patients, and the planet?



Now we have an exciting opportunity for a Quality Control Information Systems Specialist to join the Quality Control (QC) Department at our new Biologics manufacturing plant in Södertälje.



What you´ll do

Ensure all QC Laboratory Information and Acquisitions systems are managed and maintained to meet the needs of the QC testing laboratory. Provide technical support and site representation for the introduction of new QC Information Systems.



Take ownership of, and be responsible for, all actions undertaken as part of the role, to ensure that commitments to the organisation and colleagues are always met.



Manage and maintain, as appropriate, global QC information systems within the department, static data reports and permissions as well as coordinating changes with users and other trained administrators.



Provide an interface/communication between QC Information Systems Specialists, internal and global groups and the global IT-department to ensure that issues and system changes are completed within the appropriate timelines.



Actively promote continuous improvements in working practices and procedures by liaison with laboratory staff and other functions, to identify focus areas and assist in the resolution of key issues.



Participate in company intra- and inter- department problem-solving, training and teamwork initiatives, as assigned. Work closely with local business functions on project management, continuous improvement and data integrity for all systems. Responsible for developing, and implementing new informatics solutions for the QC department, including target setting and improvement plans.



Essential Requirements

* Qualified to graduate level/or equivalent in a scientific discipline
* Experience in pharmaceutical QC operations, preferably in a technical or supervisory role in addition to experience working with data management systems such as Empower, Chemstation, LabManager, Labware LIMS and MODATM Solution for environmental monitoring
* Knowledge of Laboratory data systems is essential with conversant knowledge of Microsoft packages including Excel
* A wide knowledge of QC methods, be conversant with the USP, ICH and European Pharmacopoeias and demonstrate a knowledge of industry standards for pharmaceutical product testing
* Excellent written and verbal communication skills being fluent in both Swedish and English
* Good working knowledge of manufacturing processes applicable to pharmaceutical/biopharmaceutical products



Desirable Requirements

* Experience in a Good Manufacturing Practice (GMP) environment/Good Laboratory Practice (GLP)
* Strong knowledge and understanding of analytical chemistry and laboratory instrumentation and an understanding of the Quality Control function, and it's role and importance to the business
* Previous Biopharmaceutical Industry experience
* Creativity, problem solving and independent decision making skills
* Team working and interpersonal skills
* Good attention to detail and data checking





Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines to our patients is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.



Are you already imagining yourself joining our team in Södertälje? Good, because we can't wait to hear from you!



For more information about the position please contact: QC Director & Lead Anna Breitholtz Emanuelsson: anna.breitholtzemanuelsson@astrazeneca.com.



Welcome with your application no later than September 5, 2021. Interviews will be held during the application period.