Quality Assurance Pharmacist (Italia)

Quality Assurance Pharmacist (Italia)

01 ago
|
Biotecnologie - Farmacia - Chimica
|
Italia

01 ago

Biotecnologie - Farmacia - Chimica

Italia

Quality Assurance Pharmacist - CMO QA Certification-Release
ID: 2625
Date of Posting: Jun 4, 2026
Business Area: Quality
Job Type: Direct Employee
Territory:
Full-Time or Part-Time: Tempo pieno
Seniority: Executive
Job Purpose
CMO QA Certification & Release acts as the Qualified Person (QP) Deputy, is responsible for the certification and timely release of medicinal product batches across the entire Recordati Rare Diseases (RRD) portfolio.
The role ensures that all batches released to the market fully comply with EU Good Manufacturing Practices (EU-GMP), Marketing Authorisations, the RRD Quality Management System, and the French Public Health Code.
In addition, the position is accountable for Master Data Governance within the SAP S/4HANA Quality Management (QM) module, ensuring the accuracy, completeness, and regulatory compliance of all quality‐relevant master data supporting batch certification and release activities.
Key Responsibilities
Batch Certification & Release




Act as QP Deputy for the certification and release of medicinal product batches across the full RRD portfolio.
Ensure timely release of finished products in compliance with business and regulatory timelines.
Guarantee that all batches meet EU-GMP requirements, Marketing Authorisations, internal Quality Systems, and the French Public Health Code prior to release.
Batch Documentation Review & Compliance
Review and approve batch documentation from manufacturing, packaging, and quality control activities.
Assess all quality events impacting batches (deviations, complaints, CAPAs, and change controls) to ensure full compliance before release.
Ensure completeness, accuracy, and availability of all documentation required for batch certification and release.
Quality Systems & Process Management
Design, implement, and maintain Quality Systems related to batch certification and release in line with regulatory requirements and Recordati Quality standards.
Ensure compliance with EU-GMP (including Annex 16), Market

📌 Quality Assurance Pharmacist (Italia)
🏢 Biotecnologie - Farmacia - Chimica
📍 Italia

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