Qualified Person / Sachkundige Person (gem. §14 AMG)

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

For Grünenthal Pharmceuticals GmbH & Co. KG, a legel entity of the Grünenthal Group, we are looking for a QP based in Leverkusen.

What the job looks like
Each day you'll enjoy a Variety of challenges, such as:

• As a key person in the Quality Organisation, you will be responsible also for developing and maintaining internal quality standards to ensure that processes and procedures are compliant with GxP legislation and regulations
• You assume the overall responsibility for batch release and related processes at our site in Leverkusen also being responsible for wholesale and distribution of medicinal products being released at that site
• As Qualified Person (QP) you take over the routine duties acc. to the legal requirements including the final judgement of batch disposition/release of products produced  by external contract manufacturers of Grünenthal
• You are responsible for reviewing and approving specifications for the production department
• You are responsible reviewing and approving complaints, deviations, changes and CAPAs
• In cooperation with other Quality Assurance departments as well as with  Quality Control, Supply Chain and our external partners you ensure compliance with the internal,  national and international required quality standards for our medicinal products
• You will be member of project teams managing product transfers and integration of new products ensuring that pharmaceutical and regulatory standards are followed

What you'll bring to the table
To make the most of this role and truly thrive, you should have:

• Professional degree as Pharmacist and Qualification according to § 15 (1) and (2) German Drug Act (Qualified Person) and § 52a German Drug Act (GDP Responsible Person) 
• Sound experience in Quality Assurance, Quality Control or Production for several years (international environment) 
• Excellent knowledge of respective and applicable regulations, legislation and GMP/GDP/ISO guidelines for medicinal products
• Fluent in German and English; additional languages a plus, but not required
• Good analytical skills, capability for problem solving, good organization talent and advanced presentation skills combined with excellent written and verbal communication skills
• Strong experience in leadership is preferrable
• Able of working in a global multicultural team