Experienced professional with 6+ years of experience of working in leading pharmaceutical companies. Proven track record of collaborating with cross functional teams to navigate complex regulatory landscapes and ensure product compliance across North America; Europe; Asia Pacific and Latin America regions.I hold a Master's degree in Pharmacy (specialization in Quality Assurance). Have authorization to work in US. Expertise:- GxP (Good Clinical Practices (GCP); Good Manufacturing Practices(GMP); Good Laboratory Practices (GLP))- FDA (21 CFR), ICH and EMA regulatory guidelines. - Quality Management System (QMS) like Corrective and Preventive Action (CAPA); Deviations - Document Management Systems (DMS)- Regulatory Compliance - Quality Assurance (QA)- Data Integrity (DI)Technical Skills:- MS Office (Word; Excel; PowerPoint and Outlook), Sharepoint, MS Teams and Adobe.- Track Wise; Salesforce and Veeva Vault Soft Skills:- Excellent written and verbal communication skills.- Strong project management, organization and collaboration skills.- Critical Thinking
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Senior Regulatory Affairs SpecialistFortrea Jul 2023 - Aug 2023IndiaLabcorp Drug Development is now Fortrea. -
Senior Regulatory Affairs SpecialistLabcorp Drug Development May 2021 - Jun 2023Pune, Maharashtra, India -
Regulatory Affairs SpecialistLabcorp Drug Development Apr 2019 - Apr 2021Pune, Maharashtra, India -
Junior Regulatory Affairs SpecialistLabcorp Drug Development Jan 2018 - Mar 2019 -
TraineeEmcure Pharmaceuticals Limited 2016 - 2017Pune, Maharashtra, India
Janvi Bhatt Education Details
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Quality Assurance -
Pharmacy
Frequently Asked Questions about Janvi Bhatt
What is Janvi Bhatt's role at the current company?
Janvi Bhatt's current role is Regulatory Affairs Specialist | GMP | Quality Assurance | Documentation | QMS.
What schools did Janvi Bhatt attend?
Janvi Bhatt attended Aissms College Of Pharmacy - India, Pune University.
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