We are recruiting a Senior Specialist Quality Assurance
Fresenius Kabi AB / Kemiingenjörsjobb / Uppsala
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hela Sverige Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees - more than 35,000 worldwide - develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.
The Uppsala Innovation & Development Center (I&DC Sweden) consists of approx. 30 people who are responsible for pharmaceutical development of parenteral nutrition products. This comprises design of new formulations, development and validation of analytical methods and registration stability studies.
Within the growing QA team, the overall goal as (Senior) Specialist QA is to ensure compliance to global quality standards primarily for projects within I&D, e.g. development of combination products, stability & tech transfer programs as well as infrastructure projects (e.g. lab extensions, computerized systems).
In this function you report to the Head of QA of the I&DC Sweden.
Job description:
Quality review and approval of product development documentation, e.g. technical requirements, analytical lab data, validation documentation, SOPs
Establish relevant documentation (e.g. SOPs, traceability matrix, risk analyses, Design History File)
Support implementation of the data governance strategy and ensuring data compliance oversight
Support risk management during combination product development/ design control, pharmaceutical product development; participate in Design Reviews
Quality oversight during product development and participate as representative of quality function in project teams
Change control and event management (e.g. CAPA)
Interact with packaging development, formulation and analytical development, project management, marketing, quality management, production units and suppliers
Implement internal quality management documents
Perform GMP training within the department
Support in activities related to internal and external audits
Support In quality improvements within the department
Job requirements:
MS (or PhD) in a relevant scientific or engineering discipline
At least 3-5 years' experience in quality work and knowledge about regulatory requirements regarding relevant industry standards, in particular 21 CFR 4 concerning cGMP for combination products
Knowledge about are: 21 CFR 210/211, 21 CFR 820, EU GMP, ISO 9001, 21 CFR 11, EU GMP Vol4. Annex 11.
Experience in pharmaceutical or device product development and quality risk management - design control
Very good ability of oral and written communication in English and Swedish
Ability to work independently and solution oriented
Working in multidisciplinary international teams
Experience with authority inspections (e.g. US FDA) desirable
What we offer:
Very diversified responsibilities
A highly interesting job
Freedom to act on your own initiative
This is a very interesting opportunity for a diligent, self-motivated and results oriented individual with strong personal presence and excellent interpersonal skills. If you are interested in this position and your profile matches the above requirements we are looking forward to receiving your application.
The position is a temporary employment that can turn in to a permanent employment if both parts agree after 6 months. The position is placed in Uppsala.
If you want to know more about the position you are welcome to contact Martin Schimmel, +49 6172-686 6304. Union representatives are Frank Glackin for Unionen, 018-644 773 and Teresia Karlsson for SACO, 018-644 304.
We look forward to your application! Selection and interviews will be ongoing during the whole application period, so please register your application as soon as possible.
We do not accept applications by e-mail or post.
Varaktighet, arbetstid
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Publiceringsdatum2020-12-16ErsättningEnligt avtal
Så ansöker duSista dag att ansöka är 2021-01-29
Klicka på denna länk för att göra din ansökanFöretagFresenius Kabi AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Fresenius Kabi AB (org.nr 556561-6058),
http://www.fresenius-kabi.se Jobbnummer 5491286
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