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QA Officer

Introduction


For our client, one of the world’s leading generics and speciality pharmaceutical companies, with products in approximately 145 countries and territories, are we looking for a QA Officer.


Company/Department


The QA Officer provides substantial support to the QP/QA Manager in all matters related to GMP/GDP processes and product quality for our client.
This position prepares all EU batch releases and administrative releases of products.
The function supports the change control, complaints and deviation process.
The position requires excellent inter-personal skills to assist in liaison with other departments within/outside the group in order to support quality requirements.


Function information


1. Batch release
- Preparing batch release by collecting all necessary information from suppliers
- Order QC analysis with registered analytical labs and follow-up
- Preparing bulk batch release by collecting all necessary information from suppliers and perform the first screening of the documents
- Initiating investigation and preparing, if required, deviation reports
- Organizing the collection of samples
- Updating batch and electronic register
- Interacting with external warehouse contractor to perform necessary activities

2. SOP
- Preparing draft SOPs
- Follow-up and maintain the Mylan Global SOP System

3. Product Quality Complaints
- Handling product quality complaints
- Archive the related documentation

4. Change control
- Coordinate change control activities
- Update technical files after approval change control

5. Training
- Assist in organizing trainings
- Update training records
- Archiving the training records
- Follow up on the overall training compliance status of all staff members

6. Psychotropics/Narcotics
- Updating register for psychotropics and narcotics
- Requesting import and export licenses
- Monthly reporting to FAGG / AFMPS

7. Sequential Barcodes for reimbursed products
- Ordering sequential barcodes on request of manufacturing sites
- Trimonthly reporting to RIZIV / INAMI

8. General administrative support


Requirements


- Scientific background (Pharmacist, Biomedicus, Pharmaceutical Laboratory Assistant …)
- A few years of experience in a similar job and working environment
- Excellent knowledge of English and Dutch, French is a plus
- Working experience with SAP is an advantage
- Solution driven mentality, problem solving skills
- Team player who has good written and oral communication skills and a ‘hands-on’ mentality
- Strong sense of responsibility and able to cope with and to work under pressure
- Possess ability to manage/handle multiple tasks and projects of complex nature simultaneously
- Be able to work autonomously


Information


Asmae El Addad 

0032.(0)10.80.71.14


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