Marina Rora

Selbstständig, Independent Quality & Supplier Auditor | EU GMP · ICH Q7 · ISO 9001, Self-employed

Fähigkeiten und Kenntnisse

8D
Advanced Product Quality Planning (APQP)
Environmental Management Systems
Audit reporting
EU GMP
Business processes
KPI Implementation
External audits
Certified Lead Auditor
Manufacturing Process Improvement
Failure Mode and Effects Analysis (FMEA)
Continuous Process Improvement
MS Visio
Quality Assurance
German
Corrective and Preventive Action (CAPA)
NCC
Internal & external audits
Quality Auditing
Customer Satisfaction
OHSAS
Internal audits
Quality control
Deutch
Process Engineering
ISO 14001
Quality Excellence
English
Process Flow Charts
ISO 9001
Quality Management
KPI
Quality Management in Projects
Product Safety
Production Part Approval Process (PPAP)
Quality Management System (QMS)
Products certification
Root Cause Analysis
Supplier Quality
Supplier Audits
Supplier Quality Management
Supplier Qualification
Supplier Quality Management,
Test Design
VDA
VDA 6.3

Werdegang

Berufserfahrung von Marina Rora

  • Bis heute 6 Monate, seit Juni 2026

    Independent Quality & Supplier Auditor | EU GMP · ICH Q7 · ISO 9001

    Self-employed

    Independent supplier-quality audit work for international clients across pharmaceutical manufacturing in Spain — focused on evidence, CAPA effectiveness and supplier qualification, not checklist compliance. - Conduct on-site supplier audits of pharmaceutical manufacturers. - Assess QMS, manufacturing operations, warehousing, QC laboratories, validation, documentation practices and data integrity against EU GMP, ICH Q7, ISO 9001 and applicable requirements. - Evaluate audit observations, non-conformities

  • 3 Jahre und 10 Monate, Aug. 2022 - Mai 2026

    European Market Transition & Professional Development

    Self Employed

    Relocated to Armenia, Spain and deliberately prepared for re-entry into the European Quality market. - Achieved Goethe-Zertifikat B2 in German. - Completed German recognition of my Master’s degree in Quality Management amp; Industrial Engineering at Master’s level / EQF 7. - Completed Software Testing amp; Quality Assurance training, strengthening structured defect analysis and deviation management. - Continued professional development in Quality Management, auditing and Spanish for international work e

  • 3 Jahre und 4 Monate, Apr. 2019 - Juli 2022

    Quality Manager

    Siemens

    Region: Russia, Kazakhstan. Team: Smart Infrastructre / Quality and Certification Management. Key responsibilities: End-to-end responsibility for Quality Management Systems and product certifications for medium-voltage equipment across Russia and Kazakhstan. Planned and conducted risk-based internal and supplier audits (ISO 9001, VDA 6.3), including audit execution, reporting, and CAPA follow-up. Supported supplier qualification and evaluation in collaboration with Procurement and Engineering, ensuring com

  • 8 Jahre und 1 Monat, März 2011 - März 2019

    Senior Quality Specialist

    Siemens

    Region: Russia, Kazakhstan. Team: Quality management and EHS Managed ISO 9001 internal audit systems and integrated QMS/EHS certification across multiple Siemens sites. Planned and executed internal audit programs, including reporting and corrective action follow-up. Maintained and improved quality policies, QMS documentation, KPIs, and management review inputs. Supported tender and supplier certification projects through compliance and quality assessments. Provided Quality Management support to major proj

  • 3 Jahre und 10 Monate, Jan. 2010 - Okt. 2013

    ISO 9001 auditor

    TÜV Rheinland Group

    Participated in ISO 9001 certification audits under supervision of lead auditors. Supported audit planning, on-site inspections, interviews, and reporting of findings. Gained experience in certification processes and corrective action follow-up.

  • 3 Jahre und 9 Monate, Juni 2007 - Feb. 2011

    Quality Manager

    Avicomp Services

    Implemented and managed QMS, achieving successful ISO certification and ensuring IT product certification within deadlines. Conducted internal audits and developed annual customer satisfaction surveys, fostering an improved feedback system. Trained over 20 employees on QMS processes and provided comprehensive reports to top management to enhance decision-making.

  • 8 Monate, Okt. 2006 - Mai 2007

    Quality Engineer

    Moscollector (state-owned company ensuring safety of utility lines)

    Played a vital role in achieving QMS certification by managing documentation and conducting internal audits. Ensured compliance that led to a successful certification without major findings.

  • 1 Jahr und 3 Monate, Aug. 2005 - Okt. 2006

    Quality Management System Expert

    INCOTEX LED Lighting

    Contributed to QMS certification and audit preparation, leading to successful certification outcomes. Acted as part of the team evaluating electronic products for acceptance, supporting quality benchmarks.

Ausbildung von Marina Rora

  • 1 Jahr, Sep. 2009 - Aug. 2010

    Translation and theory of translation (English)

    Moscow Linguistic Institute, Moscow, Russia

    Professional training in English translation and international professional communication, with focus on technical and business contexts.

  • 5 Jahre und 1 Monat, Aug. 2000 - Aug. 2005

    Master’s Degree

    Chuvash State University

    Diploma with honors. Master’s degree focused on Quality Management, Process Engineering, and Supplier Evaluation in industrial manufacturing. Thesis: Systematic Evaluation and Selection of Suppliers in Industrial Production. Degree officially recognized in Germany by ZAB (equivalent to Master’s lev

Sprachen

  • Русский

    C2 (Verhandlungssicher / Muttersprachlich)

  • Spanish

    B1-B2 (Gute Kenntnisse)

  • Deutsch

    C1 (Fließend)

  • Englisch

    C1 (Fließend)

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