Quality Assurance Engineer pharma

Description de l'offre

We are currently looking for Quality Assurance Engineer Operations

About the job:

Perform QA reviews for qualification and validation documentation (DQ, IQ, OQ, PQ, process validation)
Handle deviations, CAPA, and Change Control and ensures the execution and the follow up of escalation processes
Review batch records (electronics or paper) for API, Raw materials, bulk, semi-finished / finished products)
Write and assist with writing SOPs and further documents for QA.
Handle the approval and qualification of suppliers, bulk, packaging services including participation to auditing and establishing Technical/Quality Agreements.
Actively contribute to Product Quality Reviews (PQR), Continuous Process Verification (CPV); and to investigations as needed
Ensure successful Authorities inspections by participating in the preparation and the support in different roles (i.e. Backoffice, Subject Matter Expert, Scribe or Runner),

Profil recherché

Experience in Quality Assurance in a pharma or biotech company.
Master Degree (or equivalent) in Life Sciences or a related discipline.
Thorough understanding of cGMPs, Eudralex, and FDA 21 CFR regulatory requirements.
Excellent written & oral communication skills.
Languages: English (fluent)