Mathure- MS, MBA, ASQ Certified

Mathure- MS, MBA, ASQ Certified

Pharma & Biopharma | cGMP | QA Operations | Quality Systems & Compliance | Batch Release | Regulatory Compliance @ Vor Bio

About

Quality Assurance professional with 5+ years of experience across pharmaceutical and biopharmaceutical manufacturing, supporting both small molecule and advanced therapy products including cell and gene therapy.Experienced in end-to-end QA Operations, including batch record review, deviation investigations, CAPA, change control, and product disposition in cGMP-regulated environments. Proven track record supporting clinical and commercial manufacturing, with exposure to in-house production and global CMO operations. My experience is highly transferable across pharmaceutical operations, biologics, and sterile manufacturing.Core strengths include:• QA Operations (Batch Release & Disposition)• Quality Systems (Deviations, CAPA, Change Control & Root Cause Analysis)• eQMS Systems• Vendor & CMO Quality Oversight• Regulatory Compliance (FDA, Health Canada, ICH, EU GMP)Recently relocated to Canada as a Permanent Resident, I am actively seeking Quality Assurance opportunities across pharmaceutical and biopharmaceutical organizations.Open to roles in QA Operations, Quality Systems, and Compliance.

Country

-

City

Canada

Industry

Biotechnology

Skill

Leadership, Microsoft Excel, Project Management, Teamwork, Microsoft Office, Forecasting, Quality Assurance, Standard Operating Procedure (SOP), Good Manufacturing Practice (GMP), Pharmaceutical Industry, Process Validation, Process Qualification, Process Design, Minitab, Lean Six Sigma, Corrective and Preventive Action (CAPA), Failure Mode and Effects Analysis (FMEA), Quality by Design, Visio, Microsoft Word

Experience

Vor Bio

Senior QA Specialist

Vor Bio

LinkedIn
2024-2 - 2025-7 · 1 yr 6 mos
Vor Bio

Quality Assurance Associate II

Vor Bio

LinkedIn
2023-2 - 2024-2 · 1 yr 1 mo

Cambridge, Massachusetts, United States

Vor Bio

Quality Assurance Associate

Vor Bio

LinkedIn
2021-11 - 2023-2 · 1 yr 4 mos

Cambridge, Massachusetts, United States

Curia

QA Validation Specialist

Curia

LinkedIn
2021-4 - 2021-10 · 7 mos

Rensselaer, NY, United States

Cosette Pharmaceuticals, Inc.

Preventive Maintenance Intern

Cosette Pharmaceuticals, Inc.

LinkedIn
2020-5 - 2020-11 · 7 mos

New Jersey, United States

Cipla

Summer Intern

Cipla

LinkedIn
2017-5 - 2017-6 · 2 mos

Mumbai Metropolitan Region

Education

Stevens Institute of Technology

Stevens Institute of Technology

LinkedIn

Pharmaceutical Manufacturing Engineering

2019 - 2020 · 1 yr

Coursework cGMP, Pharmaceutical Dosage Forms, Validation, Biopharmaceutical Manufacturing, Quality, Statistical Analysis, Global Regulations and Compliance, Project Management Fundamentals, Engineering Economics and Cost Analysis, Medical Devices Manufacturing.

New England College

New England College

LinkedIn
2024-3 - 2026-3 · 2 yrs 1 mo
University of Mumbai

University of Mumbai

LinkedIn

Pharmacy

2014 - 2018 · 4 yrs

Coursework -Physical Organic Chemistry -Organic Chemistry -Anatomy, Physiology and Pathology -Biochemistry -Microbiology -Biotechnology -Physical Pharmacy -Pharmaceutical Engineering -Pharmaceutical Chemistry -Pharmaceutical Analysis -Pharmacology -Biopharmaceutics and Pharmacokinetics -Pharmacognosy and Phytochemistry -Cosmeticology -Clinical Pharmacy -Pharmaceutics -Dispensing Pharmacy -Hospital Pharmacy and Drug Store Management -Pharmaceutical Management -Documentation in Pharmaceutical Industry -Pharmaceutical Jurisprudence

Mathure- MS, MBA, ASQ Certified Contact Information

Email

******@***.com

Phone

(**) *** ****

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