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Open positions

Quality Assurance Assistant (m/f/x)

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.