Description
One of our clients, a multinational company in the pharmaceuticalindustry currently requires a Senior Validation Consultant forAnalytical Methods
Start: ASAP
End: 31/12/13
Location: South of Brussels
FUNCTION DESCRIPTION
Senior Consultant for Analytical Methods Validation in the Biochemistrygroup from Quality Control.
KEY RESPONSIBILITIES
* Manage and organize life cycle of analytical methods validationactivities for the entire QC Biochemistry group (about 10% of its time):
- Estimation of workload and planification of activities for the entireBiochemistry group
- Follow-up of established planning
- Reporting to Biochemistry management
* Coach junior consultants team (5-8 peoples) (about 20% of its time):
- Expert review of validation data & documents (protocols/reports)prepared by other consultants or supervisors
- Challenge validation strategies
* Produce analytical methods validation documents (about 70% ofits time):
- Establish strategy for methods to validate in collaboration withsupervisor in charge of the method
- Translate strategy into validation protocol and experimental plan andcommunicate with supervisor and lab technicians in charge of the method
- Follow-up of experiments related to validations with laboratories andcollect data
- Redaction of validation reports and submission to Validation Managerand QA
PREREQUISITES
Education:
* Scientific degree
Knowledge:
* Bilingual French/English, written compentencies in English
* Good communication skills
* Ability to work under pressure due to the requested flexibility andreactivity of the activities
* Autonomous
* Hands-on mentality
* Ability to work in project teams in a multidisciplinary environmentand a matricial organization
Experience:
* Experience in pharma & GMP is an asset.
* Deep practical experience in biochemical techniques (ELISA, MSD-HPLC,gel electrophoresis, ) is an asset.
* Confirmed experience in analytical method validation is highlyrecommended
TRAINING PERIOD:
1 month "on the floor training/coaching" is anticipated for thisposition
Tags: Validation, Methods, Pharmaceutical, Quality Control, QC,Contrôle Qualité, Analytical, Analytique, Méthodes