QA operation specialist
That's XPE. For one of our clients we are looking for: QA operation specialist Organisation description:
Are you looking for the next step in your career? You have an experience, in Quality?
Keep on reading, this is for you!
For one of our clients active in the pharmaceutical industry, XPE Pharma & Science is looking for a QA Operation Specialist.
As Quality Assurance Specialist, you will be working as part of the Quality Assurance Department and ensure that the products are manufactured, stored and packaged in accordance with cGMP
You will also support the development of GMP training packages and, if necessary, delivery of training.
Under the direction of the reporting manager, you will continuously improve QA and Compliance systems, strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections.Job description:
As QA Specialist you will be reporting to the Head of Quality:
Your main challenges:
- Investigation and closure for the Deviation and the Out Of Specifications
- Change Control initiation and implementation
- CAPA initiation and implementation / Initiation et Implémentation de CAPA
- Documentation and records review
- Procedure, Master Batch Record, Specifications… / Procédure, Master Batch Record, Specifications…
- Batch records and associated documents after production
- Control Cleaning Records
- Maintain the calibration program and the monitoring for the facilities up to date
- Documentation System Management
• You have a good knowledge of cGMP in a regulated environment (ICH Guidelines)
• You have an experience in QA of minimum 2 years, and a scientific education background
• You have an excellent accuracy and attention to detail
• Your are highly flexible and adaptable, and able to work independently in a fast paced multitasking environment
• You have a very good knowledge of French and English
• An exciting experience in leading pharmaceutical company;
• An attractive salary package with company car and extra-legal advantages;
• A fix term contract.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713