GCP Auditor
Dfind Science & Engineering AB / Kemiingenjörsjobb / Helsingborg
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Here is an opportunity to work in a global role, responsible for auditing trials in the EMEA region on the GCP and GLP regulations. You will work with products ranging from pharmaceuticals, cosmetics, OTC and Health technology. If you enjoy working independently, while having a wide range of contact areas both in and outside your organization and your passion is contributing to research being performed responsibly and with high quality this might be your next role.
Main duties:
We are looking for a Senior GCP Specialist who will be working in a global environment responsible for developing and maintaining quality systems and controls related to GCP and GLP regulations, policies and standards. You will be responsible for planning, conducting, and reporting of audits (e.g. external vendors, Trial Master Files, clinical investigator sites and documents). Furthermore you will perform and lead risk evaluations and base decisions on the outcome of the audits. In this role you will be working closely with external vendors, R & D, Regulatory Affairs, Operations, Procurement as well as with our Project Managers. To succeed in this role it is important that you can lead yourself and others and be able to work proactively in the field of GCP and GLP. Most of the work i done virtually, but there are some travels throughout the year.
You will also have the opportunity to work on a strategic level; deepening your knowledge in for example how regulations are set outside Europe, changes in the European regulations, Consumer trials and be a part of setting up structures for how to deal/work with these areas within J&J.
We are offering a dynamic, innovative and challenging position where you will work with Quality & Compliance in an independent and global role.
Qualifications:
We believe that you have an educational background in Chemistry, Bio Chemistry, Pharmacology, Pharmacy or another field with a Bachelor degree as a minimum. You have at least five years' experience in working with the GCP framework and have experience performing audits. You have advanced knowledge in the English language bot orally and in writing and it is metorious if you know Swedish or another language. We see that you are based in Sweden. To be happy in the role, it is valuable if you are used to working globally and preferably have experience from a large global company.
It is metorious if you have knowledge within and experience working with GCP, Pharmacovigilence and/or Health Technology.
McNeil is part of the Johnson & Johnson group, which makes this an opportunity to join a company where your development potential is grand and your learning curve will be steep. To enjoy this environment, we see that you are a curious, driven, structured person who easily adapts to ongoing new conditions and have a holistic way of thinking regarding your work. You enjoy collaborating, building relationships and being in various social contexts in your work environment. You thrive in a high matrix environment. You are self-motivated and you have the ability to plan and execute activities with minimal supervision. We place great emphasis on personal qualities for this role.
Company: McNeil AB a Johnson & Johnson Company
Location: Helsingborg
Job Type: Permanent position
Last day for applications: 2018-09-10
More information: This recruitment will be managed by Dfind Science & Engineering. For more information about this position please contact Recruitment Consultant Karolina Andersson 0705-736613. The selection process is on-going so please apply as soon as possible, however no later than 2018-09-10. Please send your application in English via
https://www.dfind.se/science-engineering/We look forward to your application!
Description of the organization:
Johnson & Johnson is a globally operating health care company employing approximately 129 000 people in more than 250 companies in 60 countries. Our worldwide headquarters is in New Brunswick, New Jersey, USA. McNeil AB is part of the Johnson & Johnson Family of Companies and the largest industry in Helsingborg with around 630 employees. We develop and manufacture OTC drugs and amongst our brands Nicorette is the largest and also the world-leading product for smoking cessation. We encourage our employees to an active, healthy and tobacco free lifestyle - our premises are tobacco free.
www.mcneilab.se Search words: GCP, GLP, Audits, Clinical Studies, McNeil, Pharmacovigilence, Health Technology
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-08-14ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-09-10
Ange följande referens när du ansöker: 201158577
Klicka på denna länk för att göra din ansökanKontaktKarolina Andersson
karolina.andersson@dfind.se 0705736613
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Kungsgatan 6
25220 Helsingborg
KontorsadressKungsgatan 6, 25221 Helsingborg
Jobbnummer 4288985
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