GO QA Project Manager
Fresenius Kabi AB / Kemistjobb / 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.
We're looking for a GO QA Project Manager for the region Europe. Plants to support is Uppsala/Brunna, Graz, Halden and Labesfal.
Job description
The position holder will focus on mid-term (3-6 months) quality improvement/remediation/built-up tasks in the area of current GXP.
Driving the mid-term focus will be done in close cooperation with the local plant, QA and QC management and with support of the GO staff units.
The task is to be executed mainly on-site and might be related to existing plants and/or new plant establishment projects in different countries around the globe.
Wherever possible the approach needs to be "hands on" and any documentation needed should be prepared together with the plants for closing gaps, to maximize a knowledge transfer from the position holder to the plant staff and increase knowledge at the plant.
The position holder needs to provide current GXP support and advice to the local QA, QC and plant teams in order to close possible compliance gaps in the laboratory or production and to further enhance and develop local skills and knowledge in that area.
Additionally, tasks related to the overall Quality Management System of Fresenius Kabi might be applicable as follows:
Participant in global quality system harmonization groups.
Issue and review global SOPs/Guiding Documents/Working Instructions.
Support in supplier audits.
Prepare plants for authority audits, performance of pre-audits and support during audits where applicable.
Running harmonization projects within laboratories within the GO.
Job requirements
MSc in Pharmacy/Chemistry/Biology or Chemical Engineering
Minimum 2 years of experience in the pharmaceutical GxP environment and proven knowledge on the requirements and application of pharmaceutical quality systems, EU GMP, WHO GMP, CFR210/211 and ISO 9001 and other relevant standards.
Experience from inspections/audits at QC laboratories, ideally also audit train audits/verifications.
Willingness to travel on a regular basis and on-site support of plants. The overall travel for the position holder is about 50% with 1 to 3 weeks continuous on-site work assignments.
In order to be successful in this position we are looking for a person with good communication skills, confident in English as well as a strong integrity.
Leadership skills are important as well as being able to organize multiple tasks in several plants.
We offer
Challenging position in a global leader in manufacturing sterile pharmaceuticals.
An opportunity to be driver of change and have a strong influence on improvements.
Continue our work with integrating our GO plants and setting our way of working.
Your contact
Tobias Collin
Director Organizational Development
M +46 701-58 48 28
We look forward to your application! Selection and interviews will be ongoing during the whole application period. We do not accept applications by e-mail or post.
Varaktighet, arbetstid
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Publiceringsdatum2019-04-12Ersättning•
Så ansöker duSista dag att ansöka är 2019-05-03
Klicka på denna länk för att göra din ansökanKontaktElina Frösegård
FöretagFresenius Kabi AB
AdressFresenius Kabi AB
Fresenius Kabi AB
75174 Uppsala
KontorsadressRapsgatan 7
Jobbnummer 4730030
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