Description
For one of our clients, we are currently looking for a "Validation Coordinator for regulatory files"
Location: Wavre
Start: 15/1/13
Duration: 6 months + extension
FUNCTION DESCRIPTION:
Coordinate and write the "facility and equipment" section of USregulatory files
KEY RESPONSIBILITIES:
* Ensure responsibility of writing the "facility and equipment" sectionof US regulatory File
* Ensure the coordination with the departments involved (Production,Quality Assurance, Technical, Quality Control and Regulatory affairs)in the writing/review process.
* Manage and schedule with Production, Technical, Quality Control,Quality Assurance and Regulatory departments the writing/reviewprocess, to ensure timely completion.
* Give a support to manage the regulatory authorities questions relatedto a file.
* Monitor that supportive data provided by other departments arecompliant.
* Report significant issues
EDUCATION/KNOWLEDGE/PREVIOUS EXPERIENCE REQUIRED:
Education:
* University level (agronomy, chemistry, pharmacy or biotechnology) orequivalent by experience.
Knowledge:
* Bilingual French/English
* Knowledge of biologic process
* Knowledge of process equipment
* Knowledge in qualifications of HVAC systems, Clean Utilities (CleanCompressed Air, Pure Steam, Purified Water, Water For Injection, ...),autoclaves, analytical systems, CIP/SIP process, filling lines, bulkequipments (chromatography systems, fermentor, )
* Good knowledge of projects and qualification steps.
Regulations and standard guidelines:
* cGMP
Experience:
* Over 2 to 5 years experience in vaccine production, validationor quality assurance in a biopharmaceutical industry or RegulatoryAffairs
Skills:
* Good communication skills
* Analytical skills
* Autonomous
* Ability to work in project teams in a multidisciplinary environmentand a matricial organization