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Recommended expert

Austria

Experience

Dec 2019 - Present

6 years 4 months

Munich, Germany

Lead Auditor/ Senior Product Specialist

Notified Body TÜV SÜD Product Service GmbH

Valid authorization for lead Auditor for ISO 13485; MDSAP, MDR, 9001 & Taiwan
Contracting, planning, conducting, documentation and finalizing regular, clinical and UAAs audits within the framework of the quality management systems of manufacturers of medical devices and their supply chain.
Review of QM documents and procedures
Review of regulatory and normative requirements
Responsible for MedTech GCP certification Program for hospitals, laboratories and CROs according to specially developed program based on ISO 14155, ISO 20916 and GCP
Technical Certifier authorisation for MedTech GCP
SR-CLA (Surveillance Reviewer for clinical audit files)
Preparation of training materials for clinical topics/audits
Conducting internal and external training

Jun 2017 - Present

8 years 10 months

Clinical Research Associate

Clinical Research Services Riedlsperger KG

Conduct site feasibility and pre-study site assessment visits
Responsible for executing activities within site initiation and start-up, on site and remote monitoring (RBM), site management and site/study close out
Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
Ensuring study conduct is in compliance with all relevant regulations and standards
Collaborating with experts on study sites and client representatives.
Carry out drug formulation administration procedures and documentation records.
Ensure adequacy of drug shipment and drug accountability
Provide support to the Project Manager
Study Submission to Ethic Committees and Competent Authorities

Jul 2015 - Dec 2017

2 years 6 months

Innsbruck, Austria

Study Coordinator/ Study Nurse

Innsbruck Medical University Department of Neurology / Neurocritical Care Unit

Study site management
Monitor the proper implementation and performance of the clinical trials in accordance to the ICH and GCP Guidelines, SOP and the Austrian law
Preparation and review of trial related documents, ensuring quality of source data, internal monitoring of CRF data input of medical coordinators, coordinating essential documentation and the study files (TMS / ISF)
Internal GCP and SOP´s training
Support by submission process to Ethic Committees and Authorities (AT, DE, CH)
Control and review clinical expenses against approved budget
Coordinate all clinical aspects of study

Dec 2014 - Jun 2015

7 months

Miesbach, Germany

Launch Coordinator Customer Service, Narcotic Drug Compliance Deputy CS

Acino Pharma AG

Responsible to coordinate, plan and execute activities to support the New Product Launch process in achieving successful product launches.
Lead global cross-functional team meetings conduct timely follow-ups to track project deliverables from team (Working closely with BD, Portfolio team, R&D, IP, legal, manufacturing and supply chain) coordinating all activities in launch process
Planning, executing and tracking of multiple launch projects ensuring timely regulatory submission, supply and market entry according to the approved business cases
Control, approval and formal release of packaging material according to the technical specification and national/international regulatory and legal regulations
Responsibility for regulations conform international shipment of admissions samples and investigational product samples
Overall responsibility of import and export license procedures according to narcotic regulations, assure all compliance requirements.
Legally conform and compliance reporting
Extension of the narcotic drug authorization

Jan 2005 - Mar 2013

8 years 3 months

Kufstein, Austria

Business Solution Manager CEE/ Sales Consumer Goods and Medical Films

Britton Unterland GmbH

Manage given accounts within the territory, manage customer relations, coordinate all activities to deliver customer satisfaction
Monitor customer preferences to secure new business and responsible for meeting company’s sales target.
Product development, resin qualification and executing sampling process
Independent preparation of offers and tenders for defined products
Product trainings and seminars with customers
Represent company at trade association meetings to promote products
Providing strategic business information by collecting, analyzing, and summarizing market development data

Aug 2003 - Apr 2004

9 months

Warsaw, Poland

Manager of Sales and Foreign Co-operation Section

Badis Sp. Z oo

Manager of sales and foreign co-operation section

Apr 2003 - Aug 2003

5 months

Warsaw, Poland

Contracting Coordinator Clerk/ Quality Control

Sad-Pol Agro Michalowice

Contracting Coordinator Clerk/ Quality Control

Mar 2003 - Mar 2003

1 month

Warsaw, Poland

Intern

Polish Government Department of EU Integration

Planning information campaign before EU election

Aug 2001 - Feb 2003

1 year 7 months

Gdańsk, Poland

Assistant of the Manager Director, Department Manager

Brandtex Retail Polska

Assistant of the Manager Director, Department Manager

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Healthcare, Pharmaceutical, Biotechnology, Manufacturing, Retail, and Agriculture.

Healthcare

Pharmaceutical

Biotechnology

Manufacturing

Retail

Agriculture

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Research and Development, Sales, Marketing, Product Development, and Audit.

Quality Assurance

Research and Development

Sales

Marketing

Product Development

Audit

Skills

It: Microsoft Os, Office, Sap/r, Atlas, Quesgen System Inc, Kis –Powertrials Patients Management Centricity Critical Care
Driving Licence -B
Bsb (Best Safety Behaviour) Auditor
Solid Knowledge Of Hygiene Certification 15593, Reach

Languages

Polish

Native

German

Advanced

English

Advanced

Russian

Intermediate

Education

Mar 2015 - Jul 2015

Medical University of Graz

University advanced course Clinical Trial Specialist · Clinical Trial Specialist · Graz, Austria

Jan 2014 - Jul 2014

Certified Pharmaceutical –Commercial Clerk · Pharmaceutical –Commercial Clerk · Austria

Oct 2001 - Jul 2002

University of Gdansk

Diploma degree in Economy · Economy · Gdańsk, Poland

...and 1 more

Certifications & licenses

Lead Auditor Authorization

Notified Body TÜV SÜD Product Service GmbH München

BSB (Best Safety Behaviour) Auditor

Quality Assurance Representative Course

WIFI Innsbruck

SR-CLA

Technical Certifier Authorisation for MedTech GCP

Statistics

Experience

Total positions 9

Experience in Healthcare 17 y

Avg length 3 y 2 m

Longest experience 8 y 9 m

Global Experience

Countries worked in 3 (Poland, Germany, Austria)

Primary country Poland

Expertise

Recent roles Lead Auditor/ Senior Product Specialist, Clinical Research Associate, Study Coordinator/ Study Nurse

Main industries Healthcare, Pharmaceutical, Biotechnology

Main business areas Quality Assurance, Research and Development, Sales

Qualifications

Highest degree Master

Certifications earned 5

Profile

Created

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

What languages does Honorata speak?

Honorata speaks the following languages: Polish (Native), German (Advanced), English (Advanced), Russian (Intermediate).

How many years of experience does Honorata have?

Honorata has at least 22 years of experience. During this time, Honorata has worked in at least 9 different roles and for 9 different companies. The average length of individual experience is 2 years and 5 months. Note that Honorata may not have shared all experience and actually has more experience.

What roles would Honorata be best suited for?

Based on recent experience, Honorata would be well-suited for roles such as: Lead Auditor/ Senior Product Specialist, Clinical Research Associate, Study Coordinator/ Study Nurse.

What is Honorata's latest experience?

Honorata's most recent position is Lead Auditor/ Senior Product Specialist at Notified Body TÜV SÜD Product Service GmbH.

What companies has Honorata worked for in recent years?

In recent years, Honorata has worked for Notified Body TÜV SÜD Product Service GmbH and Clinical Research Services Riedlsperger KG.

Which industries is Honorata most experienced in?

Honorata is most experienced in industries like Healthcare, Pharmaceutical, and Biotechnology. Honorata also has some experience in Manufacturing, Retail, and Agriculture.

Which business areas is Honorata most experienced in?

Honorata is most experienced in business areas like Quality Assurance, Research and Development, and Sales. Honorata also has some experience in Marketing, Product Development, and Audit.

Which industries has Honorata worked in recently?

Honorata has recently worked in industries like Biotechnology, Pharmaceutical, and Healthcare.

Which business areas has Honorata worked in recently?

Honorata has recently worked in business areas like Quality Assurance, Research and Development, and Audit.

What is Honorata's education?

Honorata holds a Master in Biology from University of Gdansk.

Does Honorata have any certificates?

Honorata has 5 certificates. Among them, these include: Lead Auditor Authorization, BSB (Best Safety Behaviour) Auditor, and Quality Assurance Representative Course.

What is the availability of Honorata?

Honorata is immediately available part-time for suitable projects.

What is the rate of Honorata?

Honorata's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.