High-quality audits and reports are key to a safe and reliable supply chain qualification. At Qualifyze we set up a quality management system (QMS) that is ISO 9001:2015 certified to ensure the highest quality standard within our work. It establishes the key processes and responsibilities of the different departments in our company.
November 5, 2020
One of the key procedures of our QMS is the qualification process for our auditors around the globe. In doing so we can provide high-quality audits, and also make sure that all Qualifyze reports maintain a common voice according to our standards. The process ensures that the auditors working for Qualifyze are the most experienced in the industry and GxP environments with the right skills and values, like impartiality and a risk-based mindset. An auditor goes through three steps in the process: a questionnaire, an interview, and a report reference. When applicable a witness audit is also included.
Our auditor qualification process
Ketty, a newly qualified auditor from Bulgaria, shared her experience from going through all these steps. After describing her skills and experience in the self-assessment questionnaire, she took part in the interview with our Head of Quality Carla. “During the interview conducted by the Head of Quality, I did not have the feeling that I am at an interview or test. It was an open conversation between professionals.” In the 45 min talk, Carla introduced herself and also Qualifyze. She explained what differentiates us from our competitors and explained our methodology, highlighting the importance of the high quality and common voice in our audit reports. Carla asked about Ketty’s responsibilities in previous jobs to figure out which positions within the Pharmaceutical industry she has experienced. An important part of the interview was the specific audit skill questions to test Ketty’s knowledge about audit preparation and conduction. “The questions aimed to confirm my knowledge of the auditing process and were practical, seeking to capture my individual approach.” Lastly, Carla asked some administrative questions and informed Ketty about the next steps of the process to become a Qualifyze auditor.
Ketty is pleased with the process. “I definitely like the Qualifyze qualification process. It was fast, but not proforma, it was detailed, but not wasting time – very well organized. And the most important – the process made me feel calm about the forthcoming task.” After becoming qualified an auditor “welcome pack” was provided to Kelly. “I am strongly confident that I will be supported by professionals during the assigned audit. The passion with which the Head of Quality described the company, its goals, and ambitions, made me believe in the success of Qualifyze.”
"In my work, I also have to assess the auditors’ qualifications. I know how important it is to work with different experts and to strive always to ensure high-quality service. Qualifyze seeks after the highest-level experts only."
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