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 (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