We are recruiting a (Senior) Expert 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&D) 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. Your overall goal as (Senior) Expert QA is to ensure quality standards primarily for projects within I&D, e.g. development of combination products, stability & tech transfer programs as well as infrastructure projects (lab extensions, computerized systems).
Job description:
Quality review and approval of product development documentation, e.g. technical requirements, validation documentation
Establish relevant documentation (e.g. traceability matrix, risk analyses, Design History File)
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)
Support tech transfers to production sites
Own the supplier management process including establishment of required quality agreements (support in audits as applicable); coordinate with global sourcing
Training of personnel on Design Control, risk management and other quality topics
Interact with packaging development, formulation and analytical development, project management, marketing, quality management, global operations, production units and suppliers
Implement internal quality management documents
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 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 21 CFR 210/211, 21 CFR 820, EU GMP, ISO 9001, 21 CFR 11 and EU GMP Vol4. Annex 11.
Experience in pharmaceutical or device product development and quality risk management - design control
Ability to work independently and solution oriented
Working in multidisciplinary international teams
Experience with authority inspections (e.g. US FDA) desirable
Experience with Lean Six Sigma is an advantage
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 person who is responsible, self-motivated. You thrive on a high level of activity in a networking role that requires assertiveness, influencing skills and ability to collaborate in international project teams. You are motivated to work in a cross-cultural atmosphere and have good oral and written communication and presentation skills, in both English and Swedish. You are well organized with a high attention to detail and show good problem-solving skills. In order to be successful in this position you need to be flexible with good interpersonal skills and set to help where it is needed in the best interest of the company.
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 Alf Niemi for SACO, 018-644 375.
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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Publiceringsdatum2019-03-13Ersättning•
Så ansöker duSista dag att ansöka är 2019-04-12
Klicka på denna länk för att göra din ansökanKontaktElina Frösegård
FöretagFresenius Kabi AB
AdressFresenius Kabi AB
Rapsgatan 7
75174 Uppsala
KontorsadressRapsgatan 7
Jobbnummer 4665498
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