GCP Auditor, Helsingborg
Randstad AB / Kemiingenjörsjobb / Helsingborg
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Here is an opportunity to work in a global role as GCP Auditor at Johnson & Johnson Consumer Health, 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. Contributing to the mission to build QA of the Future by transforming the BioResearch Quality & Compliance (BRQC) audit function to be industry-leading and to deliver innovative ways to proactively secure compliance and drive sustainability and reliability across R&D.
Do you enjoy working independently, while having a wide range of contact areas both in and outside your organization? Is your passion to contribute to research by assuring that it is performed responsibly and with high quality? Then this might be your next role!
Responsibilities
Quality Assurance is responsible for the implementation and delivery of global cross-functional compliance audit programs to ensure that the development programs, Marketing Authorization Holders, functions, processes, and systems for Consumer (and all partners) are in compliance with company standards and Health Authority guidelines and regulations.
We are looking for a 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 get to work closely with external vendors, R & D, Regulatory Affairs, Operations, Procurement as well as with our Project Managers. In these collaborations you will provide expertise, training and guidance when needed. You will also collaborate on providing strategic direction for the R&D compliance group.
You will be the process owner for selected GCP & R&D compliance SOPs and also have the chance to contribute to process improvement and development of new auditing procedures, techniques and guidelines.
To succeed in this role it is important that you can lead yourself and others and that you are able to work proactively in the field of GCP and GLP. Most of the work is done digitally, but there are some travels throughout the year.
Qualifications
To be happy and thrive in this role we believe that you bring the following experience:
A relevant university degree
Extensive knowledge in the framework of GCP and/or GLP
A minimum of three years' work experience working with GCP and/or GLP
Excellent skills in English both orally and in writing
Willingness to travel
We will be extra curious to learn more about you if you have experience in auditing and if you have experience working internationally. Knowledge in Swedish will also be a plus.
You enjoy working independently, whilst having a wide variety of contacts globally. We see that you are structured which helps you have an easy time adapting to different circumstances and environments. You are also communicative and and have a high sense of drive and motivation in your work.
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.
Application
Selection and interviews will be ongoing, so please apply as soon as possible but at latest 2022-11-06.
For more information please contact recruitment consultant Karolina Andersson,
karolina.andersson@randstad.se or 0705736613.
About the company
Johnson & Johnson Consumer is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Sweden are working to create an inclusive environment where a diverse set of backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"!
Varaktighet, arbetstid
Full time Permanent
Publiceringsdatum2022-10-17ErsättningMonthly
Så ansöker duSista dag att ansöka är 2022-11-06
Klicka på denna länk för att göra din ansökanFöretagRandstad AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "201410286".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Randstad AB (org.nr 556242-1718)
Arbetsplats Randstad
Kontakt Karolina Andersson
karolina.andersson@randstad.se +46705736613 Jobbnummer 7080455
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