Ashutosh Bhatt
Angestellt, Manager Quality and Regulatory, Kalintis Healthcare Private Limited
Vadodara, Indien
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With a decade and a half of experience in the pharmaceutical drug substance (API) manufacturing industry, I bring a wealth of knowledge and expertise to the table. As the Manager of Quality, Regulatory, and Compliance, I have been instrumental in establishing a comprehensive quality management system that strictly adheres to ICH Q7, EDQM, and USFDA compliance norms. Successfully led a USFDA facility approval inspection, resulting in zero 483s, and consistently passed multiple customer inspections across the globe. also have a proven track record of compiling and submitting drug substance DMFs, handling CRLs, Deficiencies, and life cycle management and received approval as “first adequate” for all DMFs in the first review cycle from the USFDA. Established a GLP-compliant QC instrument laboratory and implemented strict laboratory compliance procedures.
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Berufserfahrung von Ashutosh Bhatt
Bis heute 10 Jahre und 4 Monate, seit Juni 2014
Manager Quality and Regulatory
Kalintis Healthcare Private Limited
Led a team of 50+ subordinates in the areas of Quality Assurance, Quality Control, and Regulatory Affairs. Acted as the primary point of contact for FDA inspections, customer audits, and regulatory correspondence. Implemented and oversaw the entire QMS system from the inception of the manufacturing plant to USFDA Facility approval. Demonstrated strong leadership skills, ability to handle complex regulatory requirements, and a deep understanding of the API and Intermediates pharmaceutical industry.
Sprachen
Englisch
Fließend
hindi
Fließend
gujarati
Muttersprache