Quality Assurance Assistant - Mont-Saint-Guibert, België - Novadip Biosciences

Novadip Biosciences

Geverifieerd bedrijf

Mont-Saint-Guibert, België

3 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Your responsibilities:

Assist with the management (check, approval, distribution) of specifications, work instructions and other Novadip quality system documents
In collaboration with QC and the QP, assist with the management of the storage facilities for raw materials, intermediates, finished products and packaging materials
Manage the release of Novadip materials in close collaboration with the Logistics department
Manage suppliers
Revise batch records from production and quality control data
Monitor archiving and traceability of all quality system documents, with the assistance of the administrative staff when necessary
Assist with the supervision of storage conditions of products, materials and consumables
Assist with the checking and approving of certificates of analysis
Assist with the monitoring of storage conditions of clinical batches
Assist with the supervision of assignment of batch numbers to clinical batches
Assist with checking production and quality control procedures
Write, revise and check general production, QC and QA procedures
Assist with checks and monitoring within the QA department
Monitor training of Novadip personnel and their job descriptions, and ensure appropriate training is given when a person changes position
Assist with internal audits (scheduling, writing audit plans, carrying out audits, writing reports and monitoring CAPAs)
Manage external distribution of Novadip documents
Report any major event to the QA Director immediately
Assist with the review of equipment maintenance and calibration
When required, represent the company and its interests related to activities in the Quality Assurance department (contact with people external to the company, congresses, audits,)

Your profile:

You have a scientific or technical degree (at least bachelor's)
You have knowledge of GMP, preferably with at least two years' experience in QA departement, knowledge of working in aseptic conditions would be an asset
Knowledge of all other quality system norms and guidelines would be an asset
You have basic computer skills
You have very good knowledge of French (written and spoken), good knowledge of English (written and spoken)
You are thorough and respect procedures, you have excellent communication and analytical thinking skills