Quality Compliance Officer GDP

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Quality Compliance officer GDP to join Norgine.

The core responsibility of the Quality Compliance officer GDP:

The Quality Compliance Officer is responsible for providing support to the Regional clusters with regards to Good Distribution Practice (GDP) and product compliance related activities.

Quality oversight and overall responsibility on compliance of country Wholesale Dealers Licence with EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use. Act as Responsible Person Norgine GmbH according to § 52a Absatz 2 Nr. 3 Arzneimittelgesetz (AMG).

Act as Responsible Person (RP) on the Norgine Wholesale Distribution licence, in accordance with EudraLex Vol 4 and in particular EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.

Act as local person responsible for Regulatory compliance and ensure the management and Quality Assurance of the distribution activities of the medical devices. This person also have accurate knowledge of the legislation and other regulations applicable to medical devices, according local legislation. Overall responsibility according to general obligations of manufacturers (Article 10 EU Medical Device Regulation 2017/745 of the EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 for Medical Devices) lies with legal manufacturer Norgine BV.

Ensure legal entity have Wholesale Dealers licences in place that are compliant with GDP expectations set in the EC Guidelines of 5 November 2013 on GDP of medicinal products for human use.

Ensure that Norgine’s regional clusters quality management systems is maintained, under RP/Quality affiliate oversight, focusing on the management of authorised activities and accuracy and quality of records.

Releasing of medicinal product and medical devices to the market from batches received in the warehouse from different supplier and prior to distribution

· Overall responsibility of the process for National Administrative releases

· Coordinate release activities with supporting GDP colleagues

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.