MSI Pharma are working together with a multinational manufacturing company in Switzerland seeking an experienced Quality Assurance specialist CSV.

Key Responsibilities

• Responsible for Computerized System Validation (CSV) deliverables for new Large Scale Mammalian facilities, equipment and utilities related to the GMP manufacturing of biologics
• Representative of Quality in the CAPEX project organization in regards to CSV
• Reviewing and releasing quality related CSV project deliverables
• Ensure CSV deliverables meet Global procedures, regulatory requirements and policies
• Being a Subject Matter Expert (SME) and providing guidance and recommendations to internal or and external project stakeholders

Requirements

• Bachelor or Master degree in computer science, engineering, life science or related field
• Significant experience in the GMP regulated pharmaceutical industry project; preferable in a role within a Quality Unit
• Knowledge in CSV, Data Integrity and related Guidelines (21 CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each)
• Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
• Working knowledge of MES (Syncade) and DCS (DeltaV) is required
• Fluency in English, German would be an advantage