Gargi Sharma Email and Phone Number
Gargi Sharma work email
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Gargi Sharma personal email
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Personal : Passionately curious , Responsible by nature and has knack of communicating thoughts and topics with a clear and defined picture.Professional: 12 + years of experience-Expert in ISO 13485, 21 CFR 820- Certified Lead Auditor for ISO 13485:2016.-Proficient in New Product Development, Design Controls, QSR requirements, Risk Management (ISO 14971), QMS, Design Document Reviews, Verification and Validation - Expertise in partnering with Business units for their compliant Post market Quality support and customer management wrt Product Quality.- Project Management- Project Risk mitigation, Process assessment and improvement.-Experienced GMP Trainer.- Worked for Business Quality management, Plant Quality Management & R&D Quality ManagementTop 5 Gallup Strength1) Includer2) Restorative3) Responsibility4)Achiever5) Relator
Boston Scientific
View- Website:
- bostonscientific.com
- Employees:
- 32661
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Principal Quality PartnerBoston Scientific Feb 2023 - PresentGurugram, Haryana, India
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Cqa Manager (Quality Partner- Business Unit)Bd Apr 2020 - Feb 2023Gurgaon, Haryanaleading Quality Systems (post market surveillance & product technical support) of BD B2B Medical delivery solution (business unit) for entire India & South-east Asia as a business Quality partner. Project Management for process management and implementation -
Sr. Quality Engineer (R&D Quality)Stryker Jul 2017 - Jan 2020IndiaMajor Roles and Responsibilities:- Establishing Design Control Quality systems within the organization in alignment with Global system- Handling Advanced Quality Engineering Activities for various stryker products during NPDP lifecycle (Risk File Management, DIOVV Review, DHF Maintenance, conducting Design Review, PPAP)-Divisional Process Owner for NC/CAPA -Quality support in OEM product development- Certified Lead Auditor for ISO 13485:2016-Gap assessment for ISO 13485 2016 -
Assistant Manager Qa (Plant Quality & Operations)Sd Biosensor, Inc. Jul 2015 - Jul 2017Gurgaon, IndiaFactory Quality Assurance Lead (Worked on Green field project):- Started the Project from the scratch which includes from buying a land for the factory till the the launch of product in to the market .Roles Payed :- Effective implementation of all the Statutory and GMP requirements for establishing the factory for the manufacturing of IVD products.-Implementation of Quality Management system and getting the ISO 13485:2016 certification for the factory- Facility and its equipment qualification- Supplier Evaluation-GMP Trainer
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Sr Qa Executive (Plant Quality)Alere Inc. Oct 2011 - Jul 2015India-Preparation and revision of SOPs- Implementation of PLM (Agile) for Quality related activities with in the factory (NC/CAPA, COMPLAINTS)-NC/CAPA & RCA-Conducting internal Audits as well as Facilitating Global & Regulatory Audits.- Final Approval of Manufactured FG Batch records (Based on Schedule M & cGMP guidelines) and Release of Batch Release certificate for the dispatch of Finished Good to the market- Projects Handled during this tenure : Worked as a project Leader (from QA department) in SD BIO Standard Diagnostics Pvt Ltd for New ELISA Facility Expansion (Elisa Coating) & Urocolor Manufacturing process One of the core member of Novel Uncut sheet Lamination and its Coating Project (Rapid Kits) implemented in SD BIO Standard Diagnostics Pvt Ltd.
Gargi Sharma Skills
Gargi Sharma Education Details
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Maharishi Arvind Institute Of Engineering And Technology(Rtu)A -
Rrk Senior Secondry School, MoradabadA
Frequently Asked Questions about Gargi Sharma
What company does Gargi Sharma work for?
Gargi Sharma works for Boston Scientific
What is Gargi Sharma's role at the current company?
Gargi Sharma's current role is Principal QA in Boston Scientific | Ex - BD | Ex- Stryker | Ex- SD Biosensor | Ex- Alere Medical.
What is Gargi Sharma's email address?
Gargi Sharma's email address is ga****@****ail.com
What schools did Gargi Sharma attend?
Gargi Sharma attended Maharishi Arvind Institute Of Engineering And Technology(Rtu), Rrk Senior Secondry School, Moradabad.
What skills is Gargi Sharma known for?
Gargi Sharma has skills like Lifesciences, Good Communication Skills, Quality Assurance, Iso13485, Capa, Change Control, Deviation Management, Root Cause Analysis, Internal Auditor, Auditing, Validation, 21 Cfr 809.
Who are Gargi Sharma's colleagues?
Gargi Sharma's colleagues are Renee Totman, Lai Bee Heng, Paul Monskey, Marta Romero García, Eliert Alfaro, Renee Range, Kevin Schilling.
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Correspondent @Republic World | Producer @Ani | Anchor @Himalayan Network | Vp ProgrammingSiliguri
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