Birgit Steinberger Email & Phone Number

Vienna, Austria

Wien, Österreich

- External Supply/Supply Chain Market Operations Quality global DPOC for Digital Systems (eQMS, gQTS, etc.) - Global SME for product quality investigations and PoC for various SOPs- Communicating with External Supply/Supply Chain Market Operations Quality colleagues and key stakeholders on Digital Solution and/or key Quality process strategy and upcoming changes, improvement, remediation actions, and other critical activities- Coordinating updates to Master data for respective Digital Systems pertaining to External Supply/Supply Chain Market Operations Quality- Coordinating provision of data and documents as DPOC and SME for the respective Digital Systems and/or Quality process in preparation and during audits/inspections at External Supply/Supply Chain Market Operations Quality- Representing External Supply/Supply Chain Market Operations Quality in User Council Meetings for eQMS and gQTS.- Remediating respective Digital System and/or key Quality process issues through liaising with internal External Supply/Supply Chain Market Operations Quality users/SMEs/POCs, Above Site Quality, Pfizer Digital and other stakeholders.- Responsible for the project management of new system or system upgrade from the development until deployment and ensure set timelines are met.

Wien

- Global support to Supply Chain Quality Intake & Triage on complaint processing and any related inquiries - Seek solutions to remediate Complaint Intake and Triage issues through liaising with internal Supply Chain Quality users/SMEs/POCs, Above Site Quality, Pfizer Digital, and other stakeholders- Troubleshooting and supports colleagues on Complaint I&T activities- SME for global Complaint Intake & Triage SOPs- Communicates clearly and proactively with colleagues and key stakeholders on Complaint Intake and Triage strategy and upcoming changes, improvement, remediation actions, and other critical activities- Seeks to continuously improve Complaint Intake and Triage processing - Coordinates provision of data and documents for Complaint Intake and Triage process in preparation and during audits/inspections of Supply Chain Quality locations or as requested by key stakeholders- Trains & coaches Supply Chain Quality colleagues in Complaint Intake and Triage processing as applicable

Wien, Österreich

- Ensure compliance with GDP activities and local legislation - Product Complaints and Deviations Management- Local Product Release activities- Change Control Management- Out of Stock Management- Coordinated roll-out of complaints Intake & Triage Digital system at Supply Chain Central & Eastern Europe

Kundl

-Implementation of environmental monitoring and personnel qualification- Implementation of microbiological training courses- Responsible for "up to date" training documents for GMP training, hygiene training and aseptic training- Deviation management (TrackWise)- Supervision and evaluation of validations (media fills)- Participation in self-inspections, authority inspections and customer audits-Preparation of quarterly reports and trending reports- Microbiological Batch Record Review- Creation and revision of SOPs

Orth An Der Donau

- Deviation management- Change management- Creation, review and management of GMP documents- Implementation of internal GMP training courses etc.- Management of GMP documents- Implementation of internal GMP- Participation in cross-facility projects- Planning, implementation and evaluation of microbiological special investigations- Writing risk analyses- Statistical and microbiological environmental monitoring trending- Expert statements on microbiological problems- Data preparation and active participation in audits

Wien

- Proteome and cell biological methods- Statistical evaluation of data- Application of subject-specific software and bioinformatic programs- Supervision of students (internships and bachelor's theses)- Poster lectures at international congresses- Writing and publishing articles in peer-reviewed journals

Orth An Der Donau

- Processing of microbiological samples, including evaluation, assessment and recording - Water analysis and special investigations- working and recording in compliance with GMP regulations- Creation and revision of SOPs- Validations and evaluations

Doctor Of Philosophy (Phd), Genetik/Mikrobiologie, Mit Auszeichnung Bestanden

- Zell-, und Proteinisolierung - Proteinkonzentrationsbestimmungen - 1D SDS-Polyacrylamid-Gelelektrophorese - 2D.

Magistra Rer. Nat., Biologie/Molekulare Mikrobiologie, Mit Auszeichnung Bestanden

Matura