Your new company

Our client is a leading company in global biopharmaceuticals with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. With 69,000 employees operating in more than 140 countries, our client offers state-of-the-art laboratories, plants and offices that are designed to Inspire their employees as we learn, develop and grow.

In Oss, there are two large production sites that are formerly known as Organon. The first location, Biotech Operations, produces novel biologic active ingredients (“drug substance”). Their activities are split between USP (cell culturing/microbiology in bioreactors up to 22,000 litres) and DSP (filtration and purification of product). The other location, Pharmaceutical Operations, focuses on the production, packaging and distribution of various end products (tablets and injectables) and birth control products.

Your new role

The Quality Operations department within the Biotechnology site of our client must ensure adequate quality systems are in place to support the manufacturing, packaging, testing, storage, and the distribution of products according to Policies, Guidelines, Procedures and regulatory requirements through appropriate oversight and monitoring.
As QC Incoming Control Inspector, you will be primarily responsible for the incoming goods records review including correlating actions in other systems (SAP, GLIMS, etc.), and the release of incoming raw materials including relevant documentation and site SOPs.

• You will be responsible for performing Incoming Control & Supplier Management (IC&SM) investigations, Root Cause Analysis, Investigation Protocols, Change Controls and Deviation Reports.

• You will be responsible for initiating, revising and monitoring area procedures to ensure all is in compliance with cGMP regulations and site environmental protocols.

• You will be expected, when you see fit, to communicate cross-functionally between teams and suppliers to ensure overall compliance, and to handle any complaints as they come in, in a timely and efficient manner.
  
  

What you'll need to succeed

The successful candidate should have completed at least MBO/MLO education, preferable in Science with at least 5 years experience in the pharmaceutical industry and, cGMP OR Bachelor degree (HLO), preferable in Life Sciences, with 3 years experience in the pharmaceutical industry and cGMP working experience.

• Basic knowledge of quality and compliance guidelines, preferably in a GMP regulated environment.
• Basic technical knowledge of Quality testing techniques and relevant Quality Management Systems.
• Experience with Quality documentation and SAP is preferable.
• Continuous learning attitude (Lean Six Sigma), team work oriented while also having the ability to work under minimal supervision.
• Strong communication skills (oral and written) in both Dutch & English are essential.
  
  

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