Sandip Patel

Background

About Sandip Patel

With a solid 11-year track record as a Quality Assurance (QA) Specialist I possess an in-depth knowledge of international regulatory standards such as TGA APVMA USFDA MHRA EMA ANVISA and MCC within the framework of cGMP/GxP. My expertise lies in ensuring the compliance and dependability of the Quality System its related Quality Management System (QMS) and documentation. My experience extends to the QMS system and In-process Quality Assurance where I have been involved in reviewing and approving a variety of documents such as Manufacturing Batch Records Analytical Documents Change Controls Deviations Laboratory Incidents Investigations and CAPA. I have also handled the Validation profile which includes qualification validation Computer System Validation Cleaning Validation Process Validation and Vendor Qualification in a cGMP facility. This experience has strengthened my Quality Skills and allowed me to upscale. I am committed to utilizing my QA expertise to contribute to the success of the pharmaceutical industry ensuring compliance with both internal and external audits. This commitment highlights my dedication to Quality System Management. My ultimate goal is to guarantee the highest level of quality and compliance in all facets of pharmaceutical operations.