For a big biotechnology company, we are looking for a Senior International Distribution Quality Specialist. The company is in Breda and offers a one-year contract with extension!
- Provide regional support to ensure that quality system is implemented and maintained to ensure medicinal products are procured, held, supplied in a way that is compliant with the requirements of GDP.
- Provide regional support to initial and continuous training programs are in place, and accordingly maintained
- Act as Subject Matter Expert (SME) on Training matters within the region, and towards the network
- Execute Training Impact assessments within the validated Document Management System
- Perform Training assessments as part of the document creation, revision or obsoletion within the validated Document Management System
- Process online Training requests for new training assignments, updates on existing trainings, etc.
- Ensure regional and local Training Assignment Portfolios exist and are kept up to date
- Maintain IDQ onboarding manual
- Act as SME on Document Management System (DMS) within the region, and towards the network
- Act as SME on Commercial Temperature Excursions within the region, and towards the network
- Assess any temperature excursion occur during transport
- Participate in initiatives involving Commercial Temperature Excursions process improvements and updates
- Provide support to the Regional and Global SME in Product Complaints
- Provide support to the region during the deployment of Product Complaints process changes and updates
Basic Qualification and preferred requirements:
- Bachelor or MSc degree in Life sciences or related field education
- Deep understanding of Global Regulatory guidelines (Good Distribution Practice and Good Manufacturing Practice) with the ability to interpret and apply in both routine and non-routine cases
- Knowledge of warehouse and distribution processes of Medicinal products, in conjunction with sound knowledge of Quality Assurance principles
- Strong word processing, database, and spreadsheet application skills
- Fluency in English, and any additional language will be a plus
Project start date:
Short notice preferred
12 months with extension
If you are interested in the above description, please apply with your CV and a letter of motivation.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Sayf Idais at +31 (0)20 20 44 502 or by email at email@example.com???????