Regina Bendzko
Fischbach-Göslikon
Summary
Customer-focused Quality Assurance Manager with 15 years of experience in pharmaceutical and cosmetic Industry. Successful at internal audits and correctly forecasting product markets for accurate supplying. Skilled at working with customers and clients to ensure fantastic service. Hardworking with talents in strategic planning, statistical process control, and project management. Dedicated to ensuring improvements are implemented. Knowledge of data analytics and data management.
Overview
16
16
years of professional experience
Work History
QA-Manager Travel Retail DC
The Estée Lauder Companies Inc
08.2021 - Current
- Problem Solving
- Execute self-evaluations based on GMP & GDP regulations in the Distribution Centers
- Management of non-conformances noticed on products stored in Distribution Center.
- Coordinates the inspections on quality issues or nonconformances reports results and establishes Final disposition
- Ensure sampling process is managed appropriately in cases of quality defects and need of further investigations.
- Independence and Accountability
- Takes independent decisions related to the team in QA matters
- Leads projects for local deployment of the Downstream Quality Strategy
- Ensures Quality Training is in place, respecting ELC requirements and systems are rolled out.
- Assist in recall activities when applicable.
- Quality key point of contact for new DC design and acquisitions.
- Leadership
- Ensures that company goals are achieved within the Travel Retail Region and supports the long-term vision of Quality for Distribution
- Leads alignment with internal departments (Planning, Operations, Customer Services, Regulatory and ME) and colleagues from other EL plants and Global QA concerning stock status, holds and reworks of TR stored items
- Represents the QA organization in supporting Site Lead Management on Management Reviews as responsible for Quality Metrics within the Distribution Center
- Decision making/Compliance
- Ensure GMP & GDP compliance and implementation of QA processes in all the Distribution Centers.
- Establishes GMP processes for re-work Value Added Services and Late Stage Differentiation by setting standards to define product disposition.
- Establishes the Quality Management systems for the Distribution Centers and implemented documentation management systems, training management systems enabling the maintenance of appropriate records and quality documentation related to storage and shipment.
- Key Quality Contact for corporate audits and external inspections.
Export Market Compliance Lead
Takeda
09.2019 - 08.2021
- Provide operational quality oversight of distributor market
- Responsible for the management of complaints, deviations, temperature excursions from distributors
- Provide guidance and support to distributors handling of Takeda product
- Ensure coordination within GSC including GMS, RDC’s, GQ, commercial and Takeda project teams to ensure compliant supply of product to market
- Responsible to ensure GxP related activities which support Takeda’s global trading entities in supply of products are compliance and efficient
GDP Quality Compliance Manager
Takeda
09.2018 - 09.2019
- Develop and maintain the GDP Quality System
- Support all tasks related to Regional Distribution Center oversight, including:
- GDP Audits and general Regional distribution Center implementation support
- Standards and Global processes compliance
- Risks Identification and mitigation
- Record Quality KPIs
- Manage QA section of business review and site visits as needed
- Participating in Monthly RDC Committee meetings to review trends and identify follow-ups opportunities with relevant stakeholders at Manufacturing sites and Local affiliates.
- Participate and/or hold Quality Review Meetings/ with the contracted warehouses
- Report and follow-up on Critical GDP events requiring Notification to Management (escalation)
- Participate in supporting Transport Validations, as needed
- Establish appropriate communication between Regional Distribution Center, Local affiliates, Manufacturing sites and internal stakeholder responsible for GDP operations.
- Prepare and Quality Agreements for the Takeda Legal entity in Zurich to support the local entity Responsible Person
- Ensure Global GDP governance processes allow for consistent handling of Quality deviations, complaints, recalls, returns, changes and CAPAs
- Act as GDP subject matter expert for Manufacturing sites, operational groups involved in GDP activities, and local Takeda Affiliates-
- Process QA information in SAP, EQMS
- LEADs and other electronic systems electronic systems
- Support Quality Systems improvements
- Support local and global supply chain initiatives and projects
CQA Specialist (National Quality Assurance Specialist)
Baxter AG
01.2016 - 08.2018
- Review and release of all approval-relevant documents for the release of medical devices and drugs
- Preparation of necessary documents for the import of blood derivative products (notification and import application)
- Local Hold Coordinator for Switzerland and Lichtenstein
- Temperature control of storage and transport of temperature-sensitive products
- Deputy FvP
- Processing of customer tours and decision-making regarding new release or destruction
- Implementation of Field Actions (FA)
- Review of customer satisfaction (customer nature)
- Preparation and implementation of internal audits
- Execution of Corrective actions
- Preparation for 'third-party audits'
- Training of new employees
Quality Assurance Assistant
Hoffmann La Roche
04.2013 - 02.2016
- Creation of Site Master Files
- Responsible for KPI
- Set up and maintain an electronic document management system
- Management and archiving of GMP documents
- Implementation of internal processes according to global guidelines and quality standards
- Support FVP in GMP matters
Chemie Assistentin (100%)
Bircomp GmbH., Dottikon
06.2008 - 01.2013
- Worked at chemical laboratories.
- Concept development for a grass-fermentation plant
- Development and production of cosmetic products
- Administrative support of the manager
Education
Molekular Life Science -
FHNW Muttenz
11.2012
Continuing education as a chemistry technician - Laboratory technology
Hochschule Fresenius Idstein
07.2012
Fachhochschulreife - Chemical-technical assistant (Laboratory technology)
Hochschule Fresenius Idstein
09.2010
State-recognized professional college for chemical-technical assistant -
Institut Dr. Flad
08.2008
High school -
Pädagogium Baden-Baden
07.2005
Secondary level A -
Lernstudio Zürich
07.2004
Skills
- Quality Processes
- Continuous Improvement
- SOP Development
- Operation Monitoring
- Operational Improvements
- Performance Monitoring
- Management Consulting
- Documentation Control
- Team Training
- Problem-Solving Abilities
- Mastery of Quality Processes
- Issue Resolution
- Analytical Mindset
- Compliance Monitoring
- Document Management
- Audits Management
- Compliance Reporting
- Quality Controls
- System Management
- Process Management
- Program Implementation
- Document Analysis
- Process Development
- Document Reviews
- Risk Reviews
- Risk Management
- Regulatory Compliance Oversight
- Audit Oversight
- Investigative Skills
- Data Evaluation
- Audit Support
- Risk Analysis
- System Development
- Training Coordination
- Internal Audits
Knowledge And Skills
MS Office 2010 Advanced, computer writing with the ten-finger system, GMP Sharepoint Owner/Full Access knowledge, Condor condor Author and Coordinator, Trackwise Change Owner, Enroll User School, SAP, Opentext,
Personality
Quick comprehension, Ability to train yourself, Inquisitive, Structured thinking and management talent, empathic with a strong teamspirit, Communicative and open
Personal Information
- Date of Birth: 04/21/88
- Marital Status: Single
Languages
German
First Language
Russian
Proficient (C2)
C2
English
Proficient (C2)
C2
References
References available upon request.
Timeline
QA-Manager Travel Retail DC
The Estée Lauder Companies Inc
08.2021 - Current
Export Market Compliance Lead
Takeda
09.2019 - 08.2021
GDP Quality Compliance Manager
Takeda
09.2018 - 09.2019
CQA Specialist (National Quality Assurance Specialist)
Baxter AG
01.2016 - 08.2018
Quality Assurance Assistant
Hoffmann La Roche
04.2013 - 02.2016
Chemie Assistentin (100%)
Bircomp GmbH., Dottikon
06.2008 - 01.2013
Molekular Life Science -
FHNW Muttenz
Continuing education as a chemistry technician - Laboratory technology
Hochschule Fresenius Idstein
Fachhochschulreife - Chemical-technical assistant (Laboratory technology)
Hochschule Fresenius Idstein
State-recognized professional college for chemical-technical assistant -
Institut Dr. Flad
High school -
Pädagogium Baden-Baden
Secondary level A -
Lernstudio Zürich
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