Quality Engineer to I&D at Fresenius Kabi
Dfind Science & Engineering AB / Kemiingenjörsjobb / Uppsala
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Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. The company's expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients.
Fresenius Kabi in Uppsala is now looking to recruit a quality engineer to further strengthen the quality function within the Innovation & Development department and their expanding team, currently consisting of 22 employees covering analysis, formulation and quality.
Your overall goal as quality engineer is to ensure quality standards primarily for development of combination products that consists of device and pharmaceutical components.
Your responsibilities as a quality engineer are:
• Quality review and approval of product development documentation, e.g. technical requirements, validation documents
• 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, clinical development, 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
Qualifications:
We are looking for someone with a degree in science or engineering together with at least three years of experience from working in a regulated environment such as pharmaceutical and/or medtech industry. You have experience in quality work and knowledge about regulatory requirements regarding relevant industry standards, in particular 21 CFR 4 concerning cGMP for combination products. Other regulations that are relevant for the role and meritorious to have knowledge about are; 21 CFR 210/211, 21 CFR 820, EU GMP, ISO 9001, 21 CFR 11, EU GMP Vol4. Annex 11. To be successful as quality engineer in this position you also have experience in quality risk management - design control, and it is an advantage if you have experience from authority inspections and supplier management.
As a person you are responsible, self-motivated, and 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.
Employer: Fresenius Kabi
City: Uppsala
Type of employment: Full-time
Last day for application: 11th of February 2018
For information: In this recruitment process Fresenius Kabi is collaborating with Dfind Science and Engineering AB. If you have any questions regarding the position, please contact recruitment consultant Stefan Grip, 073-343 41 45 or talent manager Summer Lovlinger, 073-315 48 38. You are welcome with your application registration at
www.dfind.se/science-engineering, 11th of February 2018 at the latest. Selection and interviews will be ongoing during the whole application period, so please register your application as soon as possible.
Company description:
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.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-01-10ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-02-11
Ange följande referens när du ansöker: 201111930
Klicka på denna länk för att göra din ansökanKontaktStefan Grip
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Gamla Torget 5
75320 UPPSALA
KontorsadressGamla Torget 5, 75320 UPPSALA
Jobbnummer 3895389
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