QUALITY MANAGEMENT

• Develop and improve Quality Management Systems on company level fulfilling standards/guidelines and regulatory requirements such as: ISO 9001:2000, FDA 21 CFR Part 210, 211, 820, and 11, EU Eudralex, GAMP®5, QSR, ISPE´s guideline for Commissioning and Qualification, Lean Manufacturing, Six Sigma
• Plan and lead all quality activities within a project and develop project specific procedures as needed
• Plan and lead Risk Assessment activities related to Quality/GMP/GAMP/21 CFR Part 11
• Plan and execute GMP/GAMP/ISO audit on suppliers of mechanical and computerized systems (see also Audit)
• Plan and execute GMP audit on drug manufacturing facilities