Team · Quality Management and Sterile Manufacturing
Tatjana Pazer
Quality Management and Sterile Manufacturing
Key areas
What Tatjana stands for.
Tatjana Pazer is responsible for quality management and sterile manufacturing. She studied pharmacy, holds a licence to practise as a pharmacist and is a trained pharmaceutical technical assistant. At A&O Pharma, she works in operational QM support, strategic GxP consulting and interim management. Her areas of focus are sterile manufacturing and compounding, computer system validation and the preparation of QM documents. As an auditor, she also conducts self-inspections and supplier audits.
- Sterile manufacturing and compounding
- Computer system validation
- Efficient quality management
- Auditor
- Preparation of QM documents
Education
Degree in pharmacy, licence to practise as a pharmacist, pharmaceutical technical assistant
Responsible for 4 services
Case studies
Case studies from Tatjana's areas.
Anonymised projects from the services for which Tatjana is responsible.
Sponsor of clinical trials, small biotech company
From the IMPD to release, all from a single source
Active substance manufacture in a non-EU country, formulation development, analytics and QP release: a project combining almost all of our services.
Read the full case studyInnovative biotech company in the field of cancer therapeutics
Establishing a GMP manufacturing facility for peptide vaccines
A renowned research institution is setting up a manufacturing facility for personalised peptide vaccines, we support them from regulatory affairs thro...
Read the full case studyMid-sized company, marketing authorisation holder
Manufacturing site transfer: CMC review, transfer plan and support
Review of the marketing authorisation chapters and quality documents, risk assessments and a robust transfer plan for the planned change of manufactur...
Read the full case studyThe whole company
