Personal Information
Entreprise/Lieu de travail
Basel Area, Switzerland Switzerland
Profession
SAP Project Quality Manager
Secteur d’activité
Technology / Software / Internet
À propos
Over 10+ years of diversified experience in Pharma and IT domain with hands-on expertise in:
Pharma Domain Expertise
•Multiple USFDA, MHRA, EMEA, JP, TGA, PICs, WHO, ANVISA audit and certification experience (no 483 till date).
•Management Representative for ISO 9001, ISO 14001, ISO 14971, 15378, 27001 and OHSAS 18001 certifications.
•Customer interfacing with the Pharmaceutical and Clinical Trials industry and Chief Audit Representative for all audits.
•Product & process improvements (Lean / SPC / Six Sigma / Cycle Time / Kaizen / TQM).
•Quality Assurance of diverse product portfolios (sterile, non-sterile & medical devices.
•Regulatory filings in International Regulate
Personal Information
Entreprise/Lieu de travail
Basel Area, Switzerland Switzerland
Profession
SAP Project Quality Manager
Secteur d’activité
Technology / Software / Internet
À propos
Over 10+ years of diversified experience in Pharma and IT domain with hands-on expertise in:
Pharma Domain Expertise
•Multiple USFDA, MHRA, EMEA, JP, TGA, PICs, WHO, ANVISA audit and certification experience (no 483 till date).
•Management Representative for ISO 9001, ISO 14001, ISO 14971, 15378, 27001 and OHSAS 18001 certifications.
•Customer interfacing with the Pharmaceutical and Clinical Trials industry and Chief Audit Representative for all audits.
•Product & process improvements (Lean / SPC / Six Sigma / Cycle Time / Kaizen / TQM).
•Quality Assurance of diverse product portfolios (sterile, non-sterile & medical devices.
•Regulatory filings in International Regulate