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Analytical Methods Biochemistry Engineer (M/F) Belgium,  

CVO Europe (company)

Posted on : 19 October 2017

Project Description

Analytical Methods Biochemistry Engineer (M/F)



A Life Sciences specialist for over 20 years, CVO-EUROPE offers consulting, audit, and training services that are compliant with the regulatory requirements of the Chemical, Pharmaceutical, Biotechnology, Cosmetics, Food & Beverage, and Medical Devices industries.
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.

To support our development, we are looking for :

Analytical Methods Biochemistry Engineer (M/F)

Permanent contract

" Produce analytical methods validation documents:
- 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.

" University Degree in a scientific environment (preferrably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy) or equivalent by experience,
" 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).

publication date : 17/07/2017



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