Consultant

Sonja Bednarik

Hands-on, kind and competent Pharma professional with a strong urge to deliver.

Biography

Seasoned Quality Consultant with extensive experience in the pharmaceutical industry, specializing in quality assurance, qualification processes, and computer system validation. Adept at leading comprehensive audits, managing critical quality parameters, and facilitating regulatory compliance. Seeking to leverage expertise in a dynamic consulting role.

 

Areas of Expertise

  • Change Control & CAPAs
  • Deviations & Investigations
  • Document Review
  • Equipment Qualification
  • GMP & GLP Compliance
  • Regulatory Affairs & Reporting
  • Quality Assurance & Control
  • Quality Management Systems
  • Computer System Validation (CSV)
  • GAMP, 21 CFR Pt.11
  • Equipment IQ, OQ, PQ
  • Process Qualification (PQ, PPQ) & Validation (PV)
  • Biotechnology

 

Certifications & Training

• Certified eQMS Administrator
• SPSS Statistic
• ChemCad
• GMP/GLP Training
• Computer System Validation (CSV)

Languages
• German (Native) ● English (Fluent) ● Slovak (Basic) ● French (Basic)