
Jyoti Dhaniyasth
• Certified Lead Auditor for ISO13485 • Conversant with the regulatory Audits of USFDA, NAM, MHRA, MCC, WHO,... | Gurgaon, Gurgaon, India
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Jyoti Dhaniyasth’s Emails jy****@st****.com
Jyoti Dhaniyasth’s Phone Numbers No phone number available.
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Jyoti Dhaniyasth’s Location Gurgaon, Gurgaon, India
Jyoti Dhaniyasth’s Expertise • Certified Lead Auditor for ISO13485 • Conversant with the regulatory Audits of USFDA, NAM, MHRA, MCC, WHO, ISO, ANVISA, TGA and other regulatory bodies. • Change Control and Document control procedures • Well-versed with the 21 CFR Part 11 & ICH Guidelines requirements and its implementation strategies • Handling of Non Conformances and Exceptions • Investigations and CAPA Programmes • Ability to work effectively independently and as a team member. • Optimize the Team Performance. • Strong analytical, written and verbal communication skills. • Adaptive to the changing organizational environment to meet the business needs. • Effective Training and facilitation skills. • Providing pragmatic measures and inputs for Process improvements. • Liaising / Coordination and Negotiation with the Cross-functional teams. • Inspection Readiness.
Jyoti Dhaniyasth’s Current Industry Stryker
Jyoti
Dhaniyasth’s Prior Industry
St Jude Medical
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Medtronic
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Globallogic
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Stryker
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Work Experience

Stryker
Quality Assurance & Clinical Data Operations
Sat Dec 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Globallogic
Lead - QMS Process Management Group (India)
Tue Sep 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Dec 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Medtronic
Head - Quality & EHS (South Asia)
Tue Apr 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Aug 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
St Jude Medical
Associate Manager - QA
Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Apr 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
St Jude Medical
Senior Executive - RA/QA
Fri Oct 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Dec 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)