Analytical Methods Biochemistry Engineer (M/F) - Belgium
Analytical Methods Biochemistry Engineer (M/F)
With more than 350 consultants, CVO-EUROPE provides expertise in every activity that may affect patient health, product quality or data integrity.
CVO-EUROPE is an international group with business divisions in France, Belgium, Switzerland, and the USA.
- Establish strategy for methods to validate in collaboration with supervisor in charge of the method
- Translate strategy into validation protocol and experimental plan and communicate with supervisor and lab technicians in charge of the method
- Follow-up of experiments related to validations with laboratories and collect data
• Redaction of validation reports and submission to Validation Manager and QA
• Manages and organizes RVA (Re-Validation Assessment) reports production for the entire QC Biochemistry group:
- Estimation of workload and planification of activities for the entire Biochemistry group
- Follow-up of established planning
- Reporting to Biochemistry management
• Produces RVA reports (5 items):
1- Evaluation of potential drifts in the assay through the analysis of validity criteria history
2- Evaluation of potential drifts in the assay through the analysis of Out Of Specification (OOS) and Out Of Consistency (OOC) results history
3- Evaluation of potential drifts in the assay through the analysis of Batch History and Internal Control
4- Evaluation of potential drifts in the assay through the analysis of the changes made to the assay
5- Evaluation of compliance of existing analytical method validation report with current version of internal procedure for analytical methods validation.
• Works in collaboration with supervisors in charge of the tests in order to retrieve data for items 1-4 and in collaboration with validation team for item 5.
• Experience in pharma & GMP is an asset,
• Experience in analytical techniques is an asset and knowledge of biochemical techniques (ELISA, MSD-HPLC, gel electrophoresis,…) is highly recommended,
• Confirmed experience in assay management in GMP environment: familiar with concepts such as OOS, OOC, control charts, validity criteria, product quality review, deviation… is highly recommended,
• Confirmed experience in analytical method validation is highly recommended,
• You are mobile and flexible (the company is located in Wavre).