Sucheta Gaikwad

21CFR Part11,EU 11,Data integrity,GAMP 5,Risk Assessment,GXP,QMS (Quality & Validation Professional) Life science

Role: Team Leader at Accenture
Location: Mumbai, MH, IN
LinkedIn followers: 500 followers

General Business & ManagementView LinkedIn profile

About Sucheta Gaikwad

Gained 11 years of experience in managing functions related to, 1) Quality Assurance…

Experience

Team Leader
Accenture
Dec 2021 — Present · Mumbai, IN
21 CFR Part 11, Computer System Validation, Documentation PracticesGAMP, Automation, Data Integrity,Regulatory Requirements, EU GMP, USFDA, MHRA.Worked on Category 4 and 5. Worked on Validation Deliverables.(Validation Plan, RTM, Protocols, VSR).Worked on Validation Deliverables.(Change Request, FS,DS, VP, Quality Risk assessment, Qualification report, Installation, Integration test cases,).Have basic knowledge of HPALM, CDOCS and Valgenesis,CosmosReviewing executed test cases/ scripts/SOPs prepared by technical team as per GxP and Data Integrity Compliance.Coordinating with technical and Client for compliance of Validation Deliverables documents.Drafting and reviewing Exceptions/Deviations required to be filed for GxP requirements.Working on automation of test cases.

Education

Madhurai Kamraj University
Master's degree
Institute of Pharmaceutical Management
Post Graduate Diploma in Regulatory Affairs (Formulation and API)
Veermata Jijabai Technological Institute (VJTI)
Post Graduate in Chemical Technology
Institute of Pharmacetical
Post graduate in Pharmaceutical Quality Assurance Management
Mumbai University Mumbai
Bachelor's degree

Skills

Microsoft Excel
Microsoft Powerpoint
Sap Erp
Training Management
Trackwise
Microsoft Word
Leadership
Document Management System

Contact information

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Current company

Accenture

Business Consulting and Services · 10K employees · Grand Canal Harbour, Dublin 2, IE

Accenture helps the world’s leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed for organizations across industries. Our strategy is to be the reinvention partner of choice for our clients and lead in the safe, widespread adoption of AI, and to be the most client-focused, AI-enabled, great place to work in the world. We bring together the talent of our approximately 786,000 people with proprietary assets and platforms, deep process and industry expertise, and leading ecosystem relationships to deliver end-to-end solutions and measurable outcomes at scale. Through our Reinvention Services, we offer broad expertise across Cybersecurity, Digital Core, Finance, Industry and Enterprise, Song, Supply Chain and Engineering, and Talent, with advanced capabilities in AI and Data, Industry and Process, and Technology. We serve approximately 9,000 clients and generated approximately $70 billion in FY25 revenue. Visit us at accenture.com. This LinkedIn company page is moderated. When engaging with Accenture, we encourage everyone to: - Use common courtesy and be respectful of others. - Create your own original content and avoid content that you know to be fraudulent. - Never repost someone else's copyrighted work, unless you have permission. - Never post personal, identifying, or confidential information. We reserve the right to delete comments or posts we deem to be: - Profane, obscene, inappropriate, offensive, abusive material. - Spam, repeated comments and commercial messages and personal advertisements. - Discriminatory or that contain hateful speech of any kind regarding age, gender, race, religion, nationality, sexual orientation, gender identity or disability. - Threats; personal attacks; abusive, defamatory, derogatory, or inflammatory language; or stalking or harassment of any individual, entity or organization. - False, inaccurate, libelous, or otherwise misleading in any way.

accenture.com

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About Sucheta Gaikwad

Experience

Team Leader

Education

Madhurai Kamraj University

Institute of Pharmaceutical Management

Veermata Jijabai Technological Institute (VJTI)

Institute of Pharmacetical

Mumbai University Mumbai

Skills

Find verified contacts for anyone on LinkedIn