Elena Gamanyuk

Deviation Specialist @ Resilience

About

I am a dedicated and results-driven Quality Manager with over a decade of experience in the Medical Devices and Biopharmaceuticals industry. With my proven track record in quality management and my expertise in ISO 13485 and GMP, I am fully equipped and ready to contribute to the Biomanufacturing and MedTech industries.

Country

Canada

City

Mississauga

Industry

Pharmaceuticals

Skill

Batch Release, Root Cause Analysis, Investigation, Downstream Processing, Deviation Management, Health Canada, Biopharmaceuticals, Skilled Multi-tasker, Oral Communication, Scientific Reports, release procedures, Process Validation, Research and Development (R&D), Laboratory Skills, Good Clinical Practice (GCP), Constructive Feedback, Service Standards, Critical Thinking, Analytical Skills, Microsoft Excel

Experience

Deviation Specialist

Resilience

2025-1 - Present · 1 yr 9 mos

Mississauga, Ontario, Canada

Regional QM&RA Manager (Russia, CIS, Czech, Poland & Adriatics)

Olympus Corporation

2016-11 - 2024-1 · 7 yrs 3 mos

Successful implementation of QMS and certification ISO 9001:2015 by TUeV Rheinland (Oct 2019) and ISO 13485:2016 by TUeV Austria (Feb 2023)

Leading Quality Specialist

Siemens Healthineers

2013-7 - 2016-10 · 3 yrs 4 mos

Moscow, Russia

Siemens Graduate Program

Siemens

2011-7 - 2013-7 · 2 yrs 1 mo

Moscow (Russia), Erlangen (Germany)

The Siemens Graduate Program (SGP) is a global development initiative designed for recent graduates, offering hands-on experience, leadership training, and international exposure. Participants rotate through various Siemens business units, gaining skills in innovation, management, and cross-functional collaboration to build successful careers within the company