Grözinger Peter

Global GMP Compliance Auditor bei Roche Pharmaceuticals

Basel, Basel, Switzerland

About

Experience

  • Roche Pharmaceuticals (29 yrs 8 mos)
    • Global GMP Compliance Expert
      Oct 2011 - Present · 14 yrs 9 mos

      Global GMP Compliance Auditor: Conducts external/internal production/process and manufacturing quality control audits and risk assessments. Reports discrepancies. Prepares audit plans and understands the specific issues to be evaluated. Executes external/internal audits within established manufacturing and production controls to ensure compliance with in-house and external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma). Develops formal written reports to communicate audit results to management and regulatory compliance agencies, if applicable, and makes recommendations as appropriate. May facilitate work of external auditors during on-site visits. May conduct vendor evaluation audits to determine qualifications.

    • Head of Production
      Aug 2009 - Sep 2011 · 2 yrs 2 mos

      - Solid drug / high potent solid drug manufacturing Department - Aseptic filling Antibiotics Department - Packaging operation Department - GMP support Department - Technical support Department

    • Head of Sterile (Antibiotics/sterile Liquids) & Packaging Department
      Aug 2006 - Aug 2009 · 3 yrs 1 mo

      - Aseptic filling Antibiotics Department - Packaging operation Department - Manufacturing of WFI