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GDP Compliance Associate


The company
Our client is an innovative leader on the field of pharmaceutical biotechnology. Over the past 40 years, they have been pioneers in developing revolutionary medicine to help ill people around the world.

Role description
As GDP Compliance Associate, you will make sure that all activities work according to GDP (Good Distribution Practices) & Regional Supply Chain Network guidelines. You will be responsible for managing temperature excursion records regarding the transportation of medicine, maintaining accurate data, working on data analyses, investigate deviations, CAPA’s, work on root cause analyses, and assist various projects related to continuous improvements and GDP topics.
You will report to the Sr. Manager Supply Chain Compliance, and work with the EMEA GD organization, EMEA Supply Chain, EU Hub, Quality organizations, IS organization and external vendors.


Responsibilities
Manage temperature excursion and deviation records, lead the root cause analyses process.
Be responsible for CAPA and CAPA EV records, ensuring that they are implemented as intended.
Make sure to keep the authenticity of the company’s products, support product recalls and annual mock recall exercises.
Support the continuous improvement of the level of GDP compliance in the EU regional supply chain network.
Make sure that the stored data is accurate and assist the periodic data analyses process.

Requirements
BA degree in Life Sciences, combined with 1-2 years of experience in GDP / GMP compliance – without relevant degree, 3-4+ years of GDP/DMP experience is necessary.
Great knowledge of Quality Assurance, Good Distribution Practices, and Good Manufacturing Practices principles.
Excellent English skills, combined with an analytical, proactive, detail-oriented mindset.
Technical writing skills, and affinity with databases, spreadsheets and digital tools.
Experience in Quality Management Software systems (e.g. Trackwise, Document Management systems etc) and ERP system (SAP).