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Oud 23 mei 2017, 14:27
JohnHart JohnHart is offline
Geregistreerd: 4 januari 2016
Berichten: 130
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Standaard MSD is hiring a Quality Systems & Compliance Officer in Boxmeer

The position
The primary purpose of the position is to ensure cGMP compliance for the specifically assigned Quality Systems.

Key assignment:
• Develop, improve and maintain the assigned Quality Systems on system level. This includes areas of global and local Quality Management System (QMS) strategy.
• Create an integral and thorough insight in the quality and compliance status of the site. With your deep understanding of all (quality) processes and all relevant guidelines you are acting as an expert for colleagues with less experience within their own discipline.
• Ensure implementation of the Quality Strategy and you advise by giving direction to the departments and you ensure compliance in line with Global Policies.
• As a liaison from the Site Boxmeer, you are connected to Global Compliance Work Committees in line with assigned responsibilities. This will reflect into directions and results towards the QMS approach of Site Boxmeer.

More specific in this role you are responsible for:
• The coordination and execution of the internal and external audit program, monitoring and follow-up.
• The coordination (preparation, hosting and follow-up) of Health Authority Inspections.
• Periodic review and performance (Metric’s) reporting to the Site Quality Council of the Internal Auditing and Health Authority Inspection Systems.


Desired skills & experience

• Self-starting can do attitude.
• You promote and displays “Lean” behaviors and “Lean” culture and coach and develop your team
• You lead by example and have developed project management skills.
• You are a proven team player
• BSc degree or MSc degree

• Minimal 5 years’ experience in a comparable function within Quality (Systems)
• Minimal 10 years’ experience in the pharmaceutical industry is a preference.
• Experience within a (highly) regulated environment is a must.
• Green Belt certification is a preference

About MSD
MSD is working to help the world be well. Through our medicines, vaccines, biologic therapies and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. MSD has a workforce of almost 4500 in the Netherlands at three main sites.

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