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Sachin Darkunde

Sachin Darkunde

Sr. Regulatory Affairs

Healthcare

Pune, Pune

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About Sachin Darkunde:

Experienced Quality Assurance specialist and Quality Engineering-New Product Development with a Demonstrated history of working in the Medical Devices and Pharma Industry. Skill in Design History File, Risk Management, 21 CFR 820, ISO-14971, ISO-13485, MDR-2017, Literature review, Corrective Action & Preventive Action (CAPA), cGMP Manufacturing, GDP ALCOA+, Change Control, Deviation, NCR, etc.
A quick learner with the ability of self motivation & innovation. A team player with a strong interpersonal communication skills coupled with the ability to communicate at all level across the organization. Strong Quality Assurance/Engineering Professional with a Master of Pharmacy in Quality Assurance specialization from Dr. D. Y. Patil Institute Pune University. 

Experience

Experienced Quality Assurance specialist and Quality Engineering-New Product Development with a Demonstrated history of working in the Medical Devices and Pharma Industry. Skill in Design History File, Risk Management, 21 CFR 820, ISO-14971, ISO-13485, MDR-2017, Literature review, Corrective Action & Preventive Action (CAPA), cGMP Manufacturing, GDP ALCOA+, Change Control, Deviation, NCR, etc.

Education

Completed for M-pharm specialization in QA. 

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