QA Specialist - Sweden Biomanufacturing Center - Consulting Position - 11 months
Our production facility in Södertälje, Sweden Biomanufacturing Center (SBC), is a central part of AstraZeneca's strategy for manufacturing, quality assurance, and delivery of biopharmaceuticals. The site is undergoing an exciting expansion program with the establishment of new production facilities and production lines, enabling increased production and launch of the company's new medicines.
At SBC, we collaborate closely, look after each other and our patients. Here we shape the future of medicine by producing and delivering advanced, sustainable biopharmaceuticals while serving as a launch site for new products. We operate in a multicultural and global environment where digital solutions, our LEAN culture, and sustainability focus drive us forward. With us, you can design your own path, drive your development, and build your career.
To our Quality Operations team within Quality Assurance Biologics, we are now seeking a team member with the QA Specialist profile. Welcome to us where everyone feels a personal connection to the people we impact. We are committed to delivering the highest quality, from research in our laboratories to our large manufacturing facilities.
Your Role
You have delegated responsibility for ensuring products maintain the correct quality and meet set requirements while becoming an important part of Quality's aseptic oversight. You will support the entire manufacturing and supply chain where you are expected to act as a quality leader by coaching and serving as an expert on GMP and quality matters broadly, both within QA and in cross-functional work.
We work closely with production and together with other support functions to support the factory's deliveries by contributing the quality perspective. You will participate in investigations of complex deviations/complaints, contribute to various types of exciting projects and improvement efforts, and represent your operational area during regulatory inspections.
You have a broad network within SBC. You work independently with varying tasks in a rapidly changing environment. Therefore, you need to maintain structure in your work while remaining flexible when conditions change.
We require that you have:
A natural science university or college degree of at least 240 credits (160 points), including 7.5 credits (5 points) in microbiology.
Good knowledge of pharmaceutical manufacturing according to applicable regulations and Good Manufacturing Practice (GMP)
Very good knowledge of Swedish and English, both spoken and written
Meritorious: experience with release of sterile products
Meritorious: experience in quality assurance in the pharmaceutical industry and quality control of pharmaceuticals
We would appreciate if you have an interest in technology, systems, and processes.
To succeed in the role, you are a driven and solution-oriented person who thrives with a large network and broad collaboration across different functions. You are skilled at seeing the bigger picture and switching between long and short deadlines. You communicate in a good, trustworthy manner. Furthermore, you possess the ability to make well-founded decisions based on risk assessments and a balanced combination of scientific facts and regulations, and can justify these in a pedagogical way.
Are you ready to contribute new ideas and insights to our team? Perfect! We look forward to your application.
More information about Sweden Biomanufacturing Center:
https://youtu.be/OSj8XzlKvsM