Highlights:•Strong knowledge and understanding of quality management principles, methodologies, and tools. •Experience in developing and implementing quality assurance strategies and processes. •Skilled in identifying and resolving quality issues through root cause analysis, CAPA and Change Management. •Problem-solving and analytical skills to effectively address quality-related challenges. •Ability to lead cross-functional teams and collaborate with stakeholders to drive continuous improvement initiatives. •Strong communication and interpersonal skills to effectively communicate quality expectations and requirements to stakeholders. •Advanced user of SAP ERP, TrackWise, Microsoft Office (Word, Excel, PowerPoint, Publisher, Visio).

Skills:quality, gmp, pharma, manufacturing, audit, investigations, capa, change control, risk management

Goal:Experienced Quality Assurance Specialist with over 7 years of experience in leading pharmaceutical companies (Teva, BIOCAD, AbbVie) in various quality roles. Passionate about quality, skilled in problem-solving and very adaptable to changing environments.

Quality Manager 07/2020 - current
AbbVie, , Russia
Industry: Pharmaceutical manufacturing
Maintaining production in accordance with relevant requirements of cGMP, ICH and local procedures at Third-Party manufacturer’s site.
Awards: -All for one AbbVie Award (2023) for outstanding support and professional expertise demonstrated during the global QA Audit. -Make Possibilities Real Award (2022) for completion of campaigns and new launches in Q3-Q4 2022. -Clear&Courageous Award (2022) for preparing and leading Quality Management Review Meetings. -Make Possibilities Real Award (2020) for the great support to the product packaging validation. Achievements: ? Supported Third Party manufacturing site during preparation for the global QA Audit by having regular meetings for documentation review, providing clear audit requirements, and performing Gemba walks to simulate the actual audit process and to identify potential gaps. As a result, TPM successfully passed the global Audit without critical observations. ? Provided full QA support during full-cycle production of deep localization product. The biggest manufacturing campaign at TPM’s site was completed on-time, without any product waste overcoming many challenging factors, including equipment requiring maintenance and repair, very tight deadline due to regulatory grace period expiration for packaging materials, closing number of technical deviations, and managing a parallel production of another product with number of similar challenges.--
Quality Assurance Engineer 08/2019 - 07/2020
BIOCAD, , Russia
Industry: Pharmaceutical manufacturing
QA Engineer responsible for deviation management, product recalls and quality complaints. QA Lead for contract manufacturing project (aseptic filling). External and internal auditor.
? Significantly improved deviation management process by changing the process flow and promoting the investigational culture. The new work model was based on site’s SME collaboration instead of solely QA involvement. Agile principles were implemented: e.g., all major and critical investigations were broken down into short sprints to track the progress and to have the optimal investigation strategy. KPIs for deviation and complaints helped to make the results measurable. Training sessions were focused on importance of finding a root cause as well as on eradication of a “witch hunt”. In the first 6 months after improvements the number of timely closed deviation closure increased from 30% to 70%. ? Ensured timely release of ADVATE® product despite COVID-19 challenges in 2020. Good coordination of involved stakeholders (logistic, manufacturing, packaging, QC) from QA perspective as well as the effective management of deviations and changes caused by COVID-related limitations helped to ensure product release just in time. ? Led education lectures themed "GMP and Pharmaceutical Quality System" and "Deviation Management in GMP" for students at Russian National Research Medical University and Sechenov’s Moscow State Medical University within BIOCAD educational project.--
Quality Assurance Engineer 08/2017 - 07/2019
Teva Pharmaceuticals, , Russia
Industry: Pharmaceutical manufacturing
QA Engineer responsible for Batch Records review, investigations, and quality metrics. Deputy QA and Validation group head.
? Successfully implemented "New Investigation Culture" project, developed target KPIs for deviation management. ? Improved Product Quality Review process in accordance with Russian legislation requirements by updating the procedure. Added TrackWise workflow aided the generation of reports pertaining to deviations, changes, and complaints. Similarly, the detailed description of SAP workflow enabled the efficient generation of batch genealogy reports, leading to significant time savings. As a result, all 11 PQRs were completed on time. ? Developed and implemented procedure for handling of temperature excursions. Improved monitoring of transportation conditions for time and temperature sensitive products.--
Inspector Foreman 09/2016 - 07/2019
Teva Pharmaceuticals, , Russia
Industry: Pharmaceutical manufacturing
Oversights of manufacturing of multiple solid dosage forms.
? Developed and implemented finished product sampling in SAP which eliminated the human errors calculating the sample size.--

Yaroslavl State Medical University 09/2011 - 06/2016
, , Russia
Degree: Master's Degree
Major:Pharmacy
Master’s Degree in Pharmacy (Honours)

IrinaViugina_CV Quality, GMP, manager