Olga Valchikhina

Experience

• 

  MSD

  Aug 2014 - May 2016

  Medical Representative MCM

  Telemarketing of cardiovascular products to physicians (cardiologists and therapists) in multiple regions across Russia with developing long term, mutually beneficial partnership

• 

  Abbott

  Sept 2016 - now

  Collaboration on Regional and Divisional QMS projects and initiatives; Collaboration and engagement with stakeholders for the development and implementation of QA processes, aligned with local and global requirements; Quality performance metrics reporting for the QMRs; Support of global IT quality systems in the Russia Region, acting as Regional Business Administrator (LMS ISOtrain, DMS DARIUS and SolTRAQs); SharePoint Maintenance; Training administration, training metrics, training matrix management, training materials development; Writing and review/approval of procedures; Implementation of global quality standards and procedures; Periodical review of documents; Administration of change control process; Deviations, non-conformities and CAPA processing; Exposure to internal and global audits; Lead support for GMP inspections of Abbott sites and TPMs in various countries performed by Russian MoIT (FSI «SID&GP») including preparation for inspections and post inspection CAPAs execution). Show less QMS Maintenance; Support with execution of QMS projects and initiatives; Quality performance metrics reporting for the QMRs; Support of global IT quality systems in the Russia Region, acting as Regional Business Administrator (LMS ISOtrain, DMS DARIUS and SolTRAQs); Training administration, training metrics, training matrix management; Documentation management and change control; Deviations, non-conformities and CAPA processing; Exposure to internal and global audits; Assistance in GMP inspections for Abbott sites and TPMs in various countries performed by Russian MoIT (FSI «SID&GP»). Show less Preparation of regulatory submissions for assigned projects (cooperation with respective global and local parties involved, providing expert knowledge assessment and guidance in interpreting regulatory and authorities’ regulations; collecting documents, organizing translations; preparation of local normative document, review and approval coordination of patient information leaflet, initiation of mock-up artworks development and check of developed ones before submission).Monitoring submission timelines, tracking state register and ensuring timely responses to official Deficiency Letters from Health Authorities, performing submissions of product samples, standards, reagents, columns for laboratory testing. Show less Support of RA&QA Department with maintenance of filing system, document databases, archiving hard copies, keeping track of documents validity; organization of effective document flow with suppliers (invoices, payments, agreements); assistance with RS, columns and product samples import for registration purpose; assistance with compilation of submission packages and deficiency letters responses to Health Authorities in Russia; training administration in LMS (ISOtrain); meetings, events and trips arrangement. Show less

  • Quality Systems & Compliance Manager

    Feb 2022 - now

  • Quality Systems Specialist

    Oct 2019 - Feb 2022

  • Regulatory Affairs Specialis

    Feb 2018 - Oct 2019

  • Regulatory Department Assistant

    Sept 2016 - Feb 2018