Location: Ghent,NY, USA
About the position
The Quality Assurance consultant holds a vital and challenging role in any life science company: ensuring the quality and safety of products going to patients through building a Quality Management System.
Finding a way to balance quality with efficiency, keeping up with the ever-changing world of new products, techniques and requirements, and intensely collaborating with various other departments and stakeholders, ...
We support our clients with our profound knowledge and expertise in all quality subjects. Whether they are building a new production plant, developing new analytical methods, implementing a new quality regulation, or simply trying to solve issues and close gaps, we are there to ensure their success.
Are you up for this challenge?
Depending on your specific project, your role will be to
* Build the Quality Management System (QMS)
* Discover, track and discuss problems, non-conformities and deviations within a production plant, a laboratory, a warehouse & distribution center, ...
* Launch, execute and document quality issues & investigations
* Perform root cause analyses to determine the true source of any issue
* Devise CAPAs (corrective & preventive actions) to resolve the problems and prevent it from happening again
* Create or improve operating procedures, work instructions, templates, quality systems, etc... To keep up with an ever-changing world.
* Own change controls , assessing the impact and ensuring the quality and compliance of the business throughout any change
* Give trainings to operators, lab technicians, engineers, ... in your new procedures
* Plan, organize and execute the review and approval of qualification reports, test protocols, validation documents, ... Together with the engineers and subject matter experts
* Manage or coordinate projects to implement changes within your QMS
* Qualify, approve, monitor and periodically re-evaluate suppliers
* Prepare, assist and even lead internal and external audits
* Collect, analyze and presentquality metrics and KPIs to determine the most strategic way forward
Your profile
* A University Master's degree in a relevant scientific subject (bioscience, chemistry, pharmacy, healthcare, ...)
* A high professional level of English and fluent in Dutch
* At least a first thorough QA experience in GMP environment. Depending our your seniority, the task will be adapted
* Mobility towards at least one of our major clients located in Puurs, Beerse, Geel, Ghent, ...
* A consultancy mindset :
* Ready to jump in a new project, quickly gain the skills and knowledge needed to support your client, and seeing any challenge as an opportunity to (im)prove yourself.
* Socially fluent: build your professional network at both the client and Capgemini.
* Business acumen: Analyze and evaluate the client's organization to identify their challenges and needs, so we can offer them solutions
* Knowledge capitalization: capture and share your knowledge and expertise with other consultants and make use of Capgemini's tools to boost yourself
What we offer
* Within Capgemini, you will be part of a global company with endless opportunities, yet we offer a very individual and personal approach and follow-up of each consultant through small teams, led by dedicated Team Managers here in Belgium.
* Challenging and meaningful projects, attuned to your own skills and interests, at the most renowned pharmaceutical companies in the world.
* The entire knowledgebase and expertise of Capgemini to support you on your projects and develop your own skills through live trainings, e-learning platforms, knowledge sharing workshops, coaching by senior consultants, etc...
* An extensive and transparent career framework allowing you to plan and follow your own career path: whether you want to grow into a senior consultant/expert/architect or move into Team/Account/Solution/Project Management, we are here to help you achieve your maximum potential.
* A highly competitive and broad salary package, including company car with fuel/energy card.
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