* EU Batch & products releases
- Preparing batch release by collecting all necessary information from suppliers as well as preparing bulk batch release and perform the first screening of the documents. Updating batch and electronic register. Interacting with external warehouse contractor to perform necessary activities.
- Order QC analysis with registered analytical labs and follow-up. Initiating investigation and preparing, if required, deviation reports. Organising the collection of samples.
* SOP development & implementation according to regional guidelines
- Preparing draft SOPs. Follow-up and maintain the Mylan Global SOP System.
- Updating register for psychotropics and narcotics. Requesting import and export licenses. Monthly reporting to FAGG / AFMPS.
- Ordering sequential barcodes on request of manufacturing sites for reimbursed products.
- Trimonthly reporting to RIZIV / INAMI.
* Product quality complaints & change control
- Handling product quality complaints. Archive the related documentation.
- Coordinate change control activities, complaints and deviation process. Update technical files after approval change control.
* Scientific background
* 2 to 5 years of experience in a similar job or working environment, GDP knowledge
* Fluent in English with a good working knowledge of Dutch or French.
* Excellent interpersonal skills to assist in liaison with other departments within/outside the group in order to support quality requirements
* Problem solver
* Good written and oral communication
* Hands-on mentality
* Strong sense of responsibility
* Capable to adapt in a fast moving environment and able to deal with tight deadlines
! Attractive salary package with company car
Aline Vandermeeren: email@example.com or 016 309 509