Honorata Donnermair - Lead Auditor/ Senior Product Specialist

Austria

Experience

Dec 2019 - Present

6 years 2 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 8 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

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