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Our Quality System

Ensuring the highest quality standard

Our primary objective is to provide excellent services to customers by offering high-quality audits at competitive prices. Strategic decisions are always made with the aim of increasing customer satisfaction. We want to continuously improve the services we provide and prevent any negative customer experience. A risk-based mindset is vital to us. The auditor qualification process represents a central building block of our quality promise.

As of December 2019 our quality management system has been certified according to ISO 9001:2015 by TÜV Süd.

Process for Auditor Qualification

Auditor selection and qualification is one of our key procedures and thus deeply embedded in our Quality System. The qualification process includes different stages that need to be fully completed by the auditors to become a qualified Qualifyze auditor.

CV

  • Strong academic background in life science industries

  • Extensive knowledge and experience within the related industry (e.g. pharma, chemistry, etc.)

  • Evidence of relevant and accredited auditor training

  • Good level of English (written and spoken)

First, Qualifyze auditors need to have strong academic background in life sciences, and extensive knowledge and experience within related industry (e.g., pharma, chemicals, etc.). These academic and professional requirements will be assessed based on the candidates’ CV. It is also mandatory to have evidence of relevant and accredited auditor training courses.

Onboarding questionnaire

  • Number of audits conducted

  • Experience with relevant audit standards (e.g., GMP, GAMP, GVC, etc.)

  • Personal behaviour

  • Additional skills (language, Software such as Microsoft office, Trackwise, etc.)

Second, the candidate needs to fill out an on-boarding questionnaire which evaluates their personal behaviour, skills and information about type and number of audits conducted. If the auditor progresses into the next stage, an interview with Qualifyze is arranged.

Interview

  • Case study (if applicable)

  • Assesment and confirmation audit performance skills

  • Formalisation of qualification of auditor

  • DACI and CDA signature

Third, the auditor undergoes an interview. Herein, previously collected qualification-related information, communication skills and practical audit experiences are assessed and validated. In some cases, the candidate might be asked to perform a case study to evaluate not only their GxP knowledge but also their writing skills. Using the data collected during the previous stages, Qualifyze summarises the results and makes a final evaluation and qualification of the auditor. Qualified auditors sign a Declaration of Absence of Conflict of Interest and a Confidentiality Agreement.

Supervision

  • Review of audit report

  • Audits conducted together with Qualifyze Head of Quality

  • Satisfaction surveys with cusotmers and auditees

  • Follow-up of relevant trainings

Finally, auditors qualified under our quality system go through a continuous assessment. This might include review of reports through the Qualifyze QMS, onsite audits conducted together with our Head of Quality, customer satisfaction surveys to customer and auditees regarding auditor performance, follow up of trainings attended and regular updates from Qualifyze on regulatory news.

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