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.
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Canada
Biotechnology
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
Education

Pharmaceutical Manufacturing Engineering
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.

Pharmacy
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
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