Anna Sorokina
Cham
Summary
Before joining MARAS in 2015 I have held different positions in the GxP regulated environment. Within MARAS I took over the role of RP (FvP) for several companies holding diverse Swissmedic licenses including my current role as the Responsible Person for SwissCo CDMO Operations GmbH. I am responsible for developing and maintaining Swiss compliant Quality Management Systems, supervising and taking care of GMP- and GDP-relevant processes, representing the companies at Swissmedic inspections.
Overview
16
16
years of professional experience
Work History
Head of Quality Assurance
MARAS
Cham
02.2017 - Current
- Company Overview: Medical and Regulatory Affairs Services
- Coordination of the QA activities within MARAS AG
- Ensuring that the persons involved in QA activities are appropriately trained
- Ensuring/organizing introduction and further trainings
- Supporting other QA Managers in execution their roles as Responsible Persons (Fachtechnisch verantwortliche Person, FvP) especially during inspections, quality issues requiring notification to the Health Authorities or market actions
- Act as FvP for companies holding Swissmedic operational Licence
- This role includes the following tasks:
- Fulfill the requirements defined in the AMBV and Swissmedic Technical Interpretation
- Maintain the Quality Management System corresponding the GDP-and local requirements
- Establishment, implementation and keeping up to date the Standard operating procedures
- Change management
- Complaints management
- Supplier/Contractor management
- Conducting supplier audits
- Ensuring the product recipients are entitled to receive the medicinal products
- Ensuring the GMP/GDP requirements are fulfilled throughout the entire supply chain of the product
- Performing market release
- Ensuring that the products released to the Swiss market are in accordance with their registered specifications and were produced according the current European Good Manufacturing Practices
- Management of the returned/rejected/defect products
- Deviation and CAPA management
- Answering to the requests of the Cantonal or Swiss Authorities and be the key contact for all inquires concerning the quality of the distributed products
- Hosting Swissmedic inspections
- Ensuring that there is a documented procedure for recalls, compatible with the Swiss regulations
- Coordinating recall operations
- Ensuring the personnel is appropriately trained
- Ensures that self-inspections are performed at regular intervals
- Evaluating Product Quality Review (PQRs)
- Coordinating, attending and preparing agenda for management review Meeting
- Notifying Management on critical and major issues
- Coordinating the on-going projects
- Introducing the company to the potential customers
- Acting as a Responsible Person (FvP) for Swiss affiliates of international companies
- Medical and Regulatory Affairs Services
Quality assurance and Regulatory Affairs Manager
MARAS
Cham
06.2015 - Current
- Company Overview: Medical and Regulatory Affairs Services
- Responsible Person (FvP) for diverse companies
- This role includes the following tasks:
- Responsible Person (FvP) for a Swiss affiliate of a global company, having an import, export and trade abroad license
- RP (FvP) for a start-up company having an establishment license for the trade abroad
- Evaluation and adjustment of the QMS of a start-up company; preparation for a Swissmedic inspection to get an establishment license for the trade abroad with a successful outcome; obtaining a further contract as a deputy RP (FvP)
- Medical and Regulatory Affairs Services
Quality Assurance Specialist
Novo Nordisk
06.2013 - 08.2014
- Company Overview: International insulin producer
- Quality assurance for risk assessment, specification, design, acceptance testing, qualification and validation
- Review and support in development of URS, DQ, FAT/SAT, IQ, OQ, PQ Protocols and Reports, SOPs for production equipment, utilities, laboratory equipment and devices
- Participating in FAT
- CAPA-planning and supervising
- Training of Personal
- Collaboration with suppliers
- International insulin producer
Validation Engineer
NNE Pharmaplan
05.2012 - 06.2013
- Company Overview: International engineering company
- Execution of projects for diverse pharma producers (UCB Pharma, Novo Nordisk, R-Pharm)
- Key-tasks: risk assessment, Review of FAT/SAT, IQ, OQ, PQ -Protocols and Reports (Equipment, utilities, laboratory devices), Review of Design- Documentation
- International engineering company
Lead Validation Engineer
Moschempharm
06.2010 - 05.2012
- Tests planning for equipment and facilities (PW/WFI system; clean rooms, formulation, autoclaves, cold rooms, fridges, freezers, equipment for OSD production)
- Concept and development of validation documentation (Validation protocols and reports)
- Testers training and supervision of tests execution
- Conducting QMS- and GMP-Audits
- CAPA planning and supervision
Process Engineer
Moschempharm
09.2008 - 06.2010
- Company Overview: Russian pharma- producer
- Development and update of production documentation (manufacturing- und packaging protocols and SOPs in accordance with GMP)
- Supervision of the process, escalation of deviations
- Russian pharma- producer
Education
Authorization to use the professional title "Engineer" -
Government of Swabia
Augsburg, Germany03.2014
Qualification of Engineer - Technology of Chemical and Pharmaceutical Compounds
Mendeleev University of Chemical Technology
Moscow, Russia01.2009
Skills
10 years of experience as a Responsible Person for companies holding different GDP licenses in Switzerland
Representing companies at Swissmedic inspections
Establishment and maintenance of a QMS
Supplier management, including audits
Training
- Start-up DRA Schweiz, MEGRA, 11/03/16, 12-part seminar with final examination and certificate
- GDP Audit, Concept Heidelberg, 12/01/15, 1-day seminar with certificate
- Fachtechnisch verantwortliche Person, PTS, 11/01/15, 2-day seminar with certificate
- Computer Validation in the laboratory, PTS, 05/01/15, 1-day seminar with certificate
- Regulatory Affairs for Medical devices, University of Lübeck and Forum for Medical Devices, 04/01/15, 50-hours distance learning with final examination and certificate
- GMP-rules scope and History. GMP-Compliance in Design of Pharmaceutical Facilities. Qualification and Validation., 05/01/12, 2-day seminar with certificate
- Quality Management, GMP, 03/01/12, 1-day seminar with certificate
- Risk Assessment According to ICHQ9, ISO 31000, 02/01/12, 2-day seminar with certificate
- Implementation of Quality Management System According to ISO9001 and GMP in Pharmaceutical and Biopharmaceutical Industry, 12/01/10, 4-day seminar with certificate
- Development of Manufacturing and Packaging Protocols, 04/01/10, 3-day seminar with certificate
- General GMP-Training for Sterile Production & Visiting of Relevant Exhibitions, 2008-2009
Languages
- Russian, Maternal language
- German, Professional working proficiency
- English, Professional working proficiency
Personal Information
Date of Birth: 09/27/86
Timeline
Head of Quality Assurance
MARAS
02.2017 - Current
Quality assurance and Regulatory Affairs Manager
MARAS
06.2015 - Current
Quality Assurance Specialist
Novo Nordisk
06.2013 - 08.2014
Validation Engineer
NNE Pharmaplan
05.2012 - 06.2013
Lead Validation Engineer
Moschempharm
06.2010 - 05.2012
Process Engineer
Moschempharm
09.2008 - 06.2010
Authorization to use the professional title "Engineer" -
Government of Swabia
Qualification of Engineer - Technology of Chemical and Pharmaceutical Compounds
Mendeleev University of Chemical Technology
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