Hemendra Dave Email
Deputy General Manager @ Concept Medical
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Hemendra Dave Location
- Gujarat, India
Hemendra Dave Work
- 2023 -now Deputy General Manager @
- 2022 -2023 Project Manager - Sr. Specialist @
- 2021 -2021 Assistant General Manager Quality Assurance and Regulatory Affairs @
- 2018 -2021 Quality Assurance Regulatory Affairs Manager @
- 2016 -2017 Quality System and Regulatory Manager @
- 2015 -2016 Manager - QA and RA @
- 2014 -2015 Manager -QA and RA @
- 2011 -2014 Assistant Manager - QA and RA @
- 2010 -2011 Sr. Executive-Quality Assurance @
- 2005 -2010 Sr. Executive -Technical @ CORPORATE CHANNELS (INDIA) PVT. LTD
Hemendra Dave Education
- Mohanlal Sukhadia University, Udaipur
M.Sc. (Science)
2000-2002 - ALOK 1987-1998
Hemendra Dave Skills
- Qualified Lead Auditor
- Approved Mfg. Chemist
- Support RCA and Investigation of Complaints
- Prepare and Maintaining the Product Technical File
- Drive CAPA to close them with effective action plan
- Maintain QMS system
- Execute all audits per plan with adequate documentation
- Initiate & Support CI (Continues Improvement Projects)
- Handle and planned external cum internal audit and compliance for the same.
- FDA Approved Mfg. Chemist
- Planning and develop new QMS
- Qualified GMP- Auditor
- Initiate and support Continual Improvement projects
- GMP-Training
- Quality System
- FDA
- CAPA
- GMP
- Internal Audit
- Pharmaceutics
- ISO 13485
- Quality Auditing
- Pharmaceutical Industry
- Regulatory Affairs
- Change Control
- New Product Registration at DCGI
- Registration of New Mfg. Site at DCGI
- Iso 9000
- Quality Assurance
- Validation
- Medical Devices
- ISO
- Manufacturing
- ISO 14971
- CE marking
- Sop
- Product Development
- Management
- U.S. Food and Drug Administration (FDA)
- Corrective and Preventive Action (CAPA)
- ISO Standards
- Regulatory Requirements
Hemendra Dave Summary
- Hemendra Dave, based in Gujarat, India, is currently a Deputy General Manager at Concept Medical. Hemendra Dave brings experience from previous roles at Tata Elxsi, Advanced MedTech Solutions, Advanced MedTech Solutions. and NATEC MEDICAL. Hemendra Dave holds a 2000 - 2002 M.Sc. in Science @ Mohanlal Sukhadia University, Udaipur. With a robust skill set that includes Qualified Lead Auditor, Approved Mfg. Chemist, Support RCA and Investigation of Complaints, Prepare and Maintaining the Product Technical File, Drive CAPA to close them with effective action plan and more. Hemendra Dave has 1 emails on RocketReach.
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Others Named Hemendra Dave
Hemendra Dave
Deputy General Manager
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