Mahesh B. Wazade

Assistant Consultant- Computer System Validation & Compliance, Gxp & IT Qa- Pharma Life Sci Domain @Tata Consultancy Services

Mumbai, MH, IN
MOBILE NUMBERS
+91 *********19

Signup · Get unlimited contacts

WORK HISTORY

Jan 2023 — Present

Assistant Consultant- Computer System Validation & Compliance, Gxp & IT Qa- Pharma Life Sci Domain @Tata Consultancy Services

View department →

Mumbai, IN

Computer System Validation & Compliance, IT Quality Assurance, Regulatory IT Compliance function, Regulatory GxP Compliance, Consultant in Pharma - Life Sciences (LS) Domain at TCS in accordance with US FDA 21 CFR Part 11, EU Annex 11, MHRA Data Integrity 2018, ISPE GAMP5, US FDA Part 210, 211, 820, PIC/S, EU Volume 4, other and defined quality standards and company policies as per various rules and guidance’s.

EDUCATION

2010 — 2010

The Maharaja Sayajirao University of Baroda

GPAT 2010 Qualified

2017 — 2018

Indira Gandhi National Open University

Advanced Certificate in Information Security (ACISE)

2010 — 2012

Nagpur University

Master of Pharmacy - M. Pharm

2006 — 2010

Nagpur University

Bachelor of Pharmacy - BPharm

2009 — 2009

Indian Institute of Technology, Roorkee

GATE Qualified

2010 — 2012

Gurunanak College of Pharmacy Nagpur India

Master of Pharmacy (Q.A)

2006 — 2010

Agnihotri College of Pharmacy, Wardha

Bachelor of Pharmacy - BPharm

2017 — 2019

Indira Gandhi National Open University

Postgraduate Diploma in Intellectual Property Rights (PGDIPR)

SKILLS

Quality ManagementChange RequestsQuality by DesignComputer System ValidationDrug DeliveryAbbreviated New Drug Application (Anda)GxpRegulatory SubmissionsExcel Spreadsheet ValidationE ComplianceRegulatory RequirementsChange ManagementGlpSoftware Testing Life Cycle (Stlc)Data SecurityRegulatory AffairsTechnology TransferData IntegrityQuality SystemU.s. Title 21 Cfr Part 11 RegulationPharmaceuticsSoftware Development Life Cycle (Sdlc)FormulationCgmp ManufacturingClinical TrialsGamp 5Quality AssuranceBehavior ChangeMhraValidation21 CfrCapaHplc21 Cfr Part 11Data Backup SolutionsPharmacovigilanceGmpChange ControlAnnexure 11Good Laboratory Practice (Glp)

ABOUT MAHESH B. WAZADE

A strong competent professional over 14 years of experience in GxP Regulated…

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.

Mahesh B. Wazade — Assistant Consultant- Computer System Validation & Compliance, Gxp & IT Qa- Pharma Life Sci Domain at Tata Consultancy Services in Mumbai, MH, IN | Unifers