Conducting of the GMP and other audits within Europe. The following activities are included under the term of audit:
• Audit preparation (communication with the client and auditee, travel arrangements, collection of required information, agenda creation)
• Audit conduction at location (number of days to be determined by the client)
• Creation of the audit report
Areas of expertise:
• Quality Management System Audit
• Good Manufacturing Practice Audit
• Good Distribution Practice Audit
• Quality Control Laboratories Audit
• ISO 9001 Audit
• ISO 13485 Audit
• ISO 17025 Audit
• ISO 15378 Audit
The audits are conducted at the following sites:
• Manufacturers/suppliers of the starting materials (API, excipients) and packaging materials
• Contract manufacturers
• Contract laboratories
• Distribution and logistic service providers
• Other GMP and medical device service providers (e.g. sterilization)
Brief auditor references:
• 19 years within pharmaceutical industry (QA, QC, production, batch release, distribution)
• More than 100 audits conducted (Europe, Asia)
• The audits conducted on behalf of Novartis, Merck, Johnson&Johnson, Bayer Pharma, Hospira, Abbot Laboratories, Valeant Pharmaceuticals, Bristol-Myers Squibb, Boehringer Ingelheim, Amgen and other pharmaceutical companies
Certification and training:
• ISO 9001 Lead Auditor Certificate
• Certified QA Manager – Pharma (ECA)
• Numerous GMP training courses (please see a comprehensive list within the CV)
Residence: Rijeka, Croatia
Audit date(s) are always mutually agreed with the client.
The audit report is submitted within 7 working days following the last day of the audit.
Travel and accomodation expenses are charged additionaly according to the receipts received + VAT. In the case of a private car use, € 0,50 + VAT is charged for each kilometer.
The audit fees include all office and communication expenses such as phone calls, teleconferences, e-mails, regular mail, copies of audit report or CD/DVD media.