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GxP auditor, CSV, Training

$160/hr Starting at $2K

In the tenure of 21 years’ service, he served as quality control microbiology laboratory professional and Quality Compliance manager in Orchid Healthcare, served as Senior Team Leader for Audit and compliance in Strides Arcolab, later as Corporate Global Quality Head for Xellia Pharmaceutical Inc, Denmark, Johnson & Johnson Regional Compliance Manager for Johnson & Johnson Asia Pacific and Country Director for EU Consulting firm operations.

For last 6 years, he has been associated with various international consulting firms located in USA, UK, Mexico, China, Italy and India supported for GxP Audits worldwide, FDA Remediation Projects, Technical Trainings for clients located globally. He makes regular webinars/seminars around the world on Quality, Validation, Microbiology, Sterility Assurance, Risk management and Computerized System Validation services.

He is expertise in technical GxP Assessment, Data Integrity Audit and FDA Remediation projects worldwide and executed key FDA preparation and remediation projects worldwide. 

He has faced many regulatory inspections from PMDA, USFDA, UKMHRA, ANVISA, MCC, GCC, TGA, KFDA and other worldwide.

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$160/hr Ongoing

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In the tenure of 21 years’ service, he served as quality control microbiology laboratory professional and Quality Compliance manager in Orchid Healthcare, served as Senior Team Leader for Audit and compliance in Strides Arcolab, later as Corporate Global Quality Head for Xellia Pharmaceutical Inc, Denmark, Johnson & Johnson Regional Compliance Manager for Johnson & Johnson Asia Pacific and Country Director for EU Consulting firm operations.

For last 6 years, he has been associated with various international consulting firms located in USA, UK, Mexico, China, Italy and India supported for GxP Audits worldwide, FDA Remediation Projects, Technical Trainings for clients located globally. He makes regular webinars/seminars around the world on Quality, Validation, Microbiology, Sterility Assurance, Risk management and Computerized System Validation services.

He is expertise in technical GxP Assessment, Data Integrity Audit and FDA Remediation projects worldwide and executed key FDA preparation and remediation projects worldwide. 

He has faced many regulatory inspections from PMDA, USFDA, UKMHRA, ANVISA, MCC, GCC, TGA, KFDA and other worldwide.

Skills & Expertise

ConsultantQuality AssuranceTraining

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