Shilpi Sinha Email and Phone Number
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Shilpi Sinha personal email
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Shilpi Sinha phone numbers
• A seasoned Quality Assurance/ Quality Systems/ Regulatory compliance leader with 25+ years of diverse experience in the Pharmaceutical, In-Vitro Device and Medical Device industry.• Comprehensive knowledge and application of 21CFR820, 21CFR806, ISO 13485, ISO 14971, IVDD, IVDR, MSDAP, MDD, MDR.• Led/ Hosted successfully multiple Regulatory Audits over 25 years.• Certified Medical Device Auditor (ASQ/CMDA) and Regulatory Affairs Certification (RAPS) certified.• Proven track record for executing complicated and multi-faceted projects with teams across the globe.• Extensive experience in managing, leading, mentoring, and coaching small and large teams.Certified Biomedical Auditor (ASQ). Regulatory Affairs Certification (RAC-US) certified. Areas of proficiency include: Corrective & Preventive Actions (CAPA)Risk ManagementRegulatory Audits & RemediationChange Control & Document ControlNew Product Development (Design Control)Product Quality (In coming QA, Final Product Release)Complaints / Recalls / MDRs Post Market Surveillance Team Leadership and CoachingNonconforming Material (NCR)DeviationsContinuous Process ImprovementsSupplier ManagementProduct Life Cycle Management including Software.
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Head Of Quality And Regulatory AffairsArgen CorporationSeattle, Wa, Us -
Head Of Quality & Regulatory AffairsArgen Corporation May 2023 - PresentSan Diego, California, Us
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Director Quality AssuranceInova Diagnostics May 2013 - May 2023Bedford, Ma, Us -
Quality Assurance DirectorInova Diagnostics May 2013 - May 2023Bedford, Ma, Us
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Quality & Regulatory Affairs ManagerHemocue Inc, Quest Diagnostics Oct 2012 - Apr 2013
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Quality Systems ManagerFocus Diagnostics,Quest Diagnostics Jan 2007 - Oct 2012Responsible for:Validation SystemCAPA systemAudits(Internal/External/Supplier)Risk Management System
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Qa And Regulatory Affairs ManagerPeptisyntha Inc.( A Solvay America Company) 2005 - 2007
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Quality Process Compliance ManagerSolvay Draka ( A Solvay America Company) 2002 - 2005
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Quality OfficerAventis 1997 - 2001
Shilpi Sinha Skills
Shilpi Sinha Education Details
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University Of MumbaiMicrobiology -
Asq - CmdaCertified Medical Device Auditor Also Known As Certified Biomedical Auditor
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Regulatory Affairs Professional Society (Raps)Regulatory Affairs Certification
Frequently Asked Questions about Shilpi Sinha
What company does Shilpi Sinha work for?
Shilpi Sinha works for Argen Corporation
What is Shilpi Sinha's role at the current company?
Shilpi Sinha's current role is Head of Quality and Regulatory Affairs.
What is Shilpi Sinha's email address?
Shilpi Sinha's email address is sh****@****hoo.com
What is Shilpi Sinha's direct phone number?
Shilpi Sinha's direct phone number is +156224*****
What schools did Shilpi Sinha attend?
Shilpi Sinha attended University Of Mumbai, Asq - Cmda, Regulatory Affairs Professional Society (Raps).
What skills is Shilpi Sinha known for?
Shilpi Sinha has skills like Capa, Fda, Iso 13485, Quality System, 21 Cfr Part 11, Gmp, Iso 14971, Quality Auditing, V&v, Medical Devices, Regulatory Affairs, 21 Cfr.
Who are Shilpi Sinha's colleagues?
Shilpi Sinha's colleagues are Alberto Tarkaya S, Veronica Corrales, Adrian Lopez, Erome Lucas, Celeste Sferra Rinehart, Galdino Gomez, Christopher Vogel.
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