QA Assistant

Contenido de trabajo

NOVADIP BIOSCIENCES is an innovative biotech company, based in the Walloon Region (Mont-Saint-Guibert), with a strong expertise in the development of a unique 3M³ tissue regeneration platform, which utilizes adipose-derived stem cells within a 3-dimensional extracellular matrix, to drive multiple product classes, Novadip’s mission is to provide innovative solutions for patients with limited or no effective treatment options.

If you are sharing the vision of developing life-improving and life-saving products and if you are looking for new challenges amongst a dynamic and innovative team, consider collaboration with this fast-growing company.

In order to support this challenging development, NOVADIP BIOSCIENCES is actively looking for (m/f/x):

QA Assistant

Your responsibilities

• Supervise the strict application of cGMP, GCP and GLP regulations during each step of the production and analysis of batches of experimental medicinal products
• 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
• Organise implementation and application of CAPAs following all types of events (OOS, audit, change, etc.)
• 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 (Bachelor or equivalent experience)
• You have knowledge of GMP, preferably with at least one year’s experience in a company, 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

Offer:

• An attractive salary package with advantages
• To work in a human-sized, dynamic, respectful and professional environment
• The opportunity to take part in a challenging scientific and business growth.

Interested?

Please apply by email to careers@novadip.com. We guarantee your information will be handled confidentially.