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GMDP-0035

Quality Advisor

En mission
23
Années d'expérience
GMP - Good Manufacturing Practice
Spécialisation
—
Localisation
À propos de cet expert

Dear Team, Throughout my career, I have developed extensive experience in radiopharmaceutical manufacturing and in the broad range of technical, quality and operational areas supporting pharmaceutical production. My experience includes GMP-compliant sterile manufacturing, lyophilization, process and facility development, qualification and validation, quality systems, technology transfer and R&D. In addition to radiopharmaceuticals, I also gained experience in veterinary pharmaceutical manufacturing, including working within a contract manufacturing environment. After more than 20 years in the industry, I would now like to direct my career towards auditing and technical consultancy, and make more effective use of this accumulated practical experience. I see GMP auditing and GMP consultancy as a particularly valuable way of combining my technical background, manufacturing experience and understanding of pharmaceutical quality systems with a new professional direction. Although I do not currently hold a formal accredited auditor certification, I have gained practical experience both in conducting audits and in preparing for and supporting GMP inspections and external audits by regulatory authorities, customers and other organizations. I believe my specialized experience in radiopharmaceuticals, together with my broader experience in sterile pharmaceutical manufacturing, lyophilization, quality systems and contract manufacturing, could bring a valuable perspective to your auditor or expert network.

Compétences

Expert
Radiopharmaceuticals GMP Auditing Internal auditing
Avancé
Deviation Management Change Control Sterile manufacturing CAPA Management Facility qualification
Intermédiaire
API Manufacturing Supplier Auditing Process Validation

Certifications

Medical QMS Basic Training & Internal Auditor Certification (ISO 13485:2016) Internal Quality & Environmental System Auditor (ISO 9001/14001) Technology & Analytical Method Transfer and Process Validation with QbD Approach Lifecycle Approach for Analytical Methods Eudralex Vol 4 Part I–II: GMP for Medicinal Products & API Manufacturing Equipment Qualification & Validation, Risk Assessment Pharmaceutical Water Systems: Design, Operation & Maintenance GMP/GLP Applications Sterilization in the Pharmaceutical Industry Lyophilization Techniques European Radiopharmacy Course II–III (Radiopharmacy Production & Nuclear Medicine Applications) European Radiopharmacy Course I (Sterile Manufacturing & Basic Pharmacy) Project Management & Effective Resource Utilization Developing Manager Program Train-the-Trainer Program
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