Support the QP in batch certification and release
Perform and oversee batch record review and GMP documentation approval
Manage and assess deviations, investigations, CAPAs and Change Controls
Provide senior QA support directly to sterile / aseptic manufacturing operations
Ensure GMP compliance and contribute to continuous improvement on the shopfloor
Support inspections, customer audits and inspection readiness
Act as a Quality interface between Production, QC, QA, Release and external customers
Contribute actively to the further development and visibility of the Quality organization

Several years of solid operational QA experience within pharmaceutical manufacturing
Strong and recent experience in sterile / aseptic manufacturing
Substantial experience in batch review, batch disposition and/or release
Previous Deputy QP / QP experience or close operational involvement in QP release activities
Sound expertise in deviations, CAPA, Change Control and GMP compliance
Proven ability to work independently and take decisions in a manufacturing environment
French fluent, with good professional English
Stable pharmaceutical industry background; experience within CDMO or smaller manufacturing organization is an advantage
Based within realistic commuting distance or genuinely open to relocation to the region

Deputy Qualified Person – Sterile Manufacturing

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