GMDP-0035
Quality Advisor
About This 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.
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