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Medical Health Service Division/PAL Certification Group Manager
I Joined through Referral Recruiting
I was working in the same industry as my previous job before and was invited by a TÜV SÜD employee at the time. I was interested, so I decided to join. With anxiety and hope for the new work environment, I tried to do what I could step by step, not imagining at all that a few years later I would be assigned to become a manager.
“Support Clients in Expressing Their Passion for Their Products through Documents” -This is Our Mission as PAL Accessors
Unlike other auditing teams, the application for pharmaceutical affairs certification is not lead by the German headquarters, so we have a high degree of business independence / freedom, which means that it is up to us to make decisions and conduct project, showing your way of handling things. Some things cannot be read just from the written contents of the application forms, which makes it necessary to proceed with the audit while clarifying the details through hearings with the customer. This requires logical analysis ability and communication skills. In addition, if there are any deficiencies, it is necessary to explain objectively from the customer's point of view so as not to impose opinions, making it necessary to be very careful about the way of communicating. Depending on the customer, it is necessary to evaluate and audit applications for multiple medical devices at the same time, which requires very detailed task management. Successfully finishing these complicated tasks feels just like solving a puzzle and the sense of accomplishment is just great. is.
How You Add Special Value for Clients on Top of your Excellent Knowledge of Pharmaceutical Products and Medical Devices Defines You as a Good Accessor
Because this is a niche industry, you get opportunities to obtain information and experience from a different perspective than medical device manufacturers, and while being exposed to cutting-edge medical devices, laws and regulations, there are plenty of opportunities for challenges and growth. I think that people who can demonstrate performance or provide added value from the customer's perspective will have plenty of opportunities to play an active role. From my story of professional excellence, I myself participate in industry activities, external conferences and our in-house training Regional High-Potential Development Program, and although it is difficult to balance with daily work, I can utilize the experience gained from these for audit work and team management. I find it very rewarding.
Compared to other companies where you have to do audits both for domestic and international standards, TÜV SÜD is separating the two areas which allows you to dedicate your energy towards PAL audits, so I think it is a good environment to become an expert.
TÜV SÜD Provides Productive Trainings to Support Your Challenge
I think that joining TÜV SÜD in my early 30s and taking on various challenges has led to my confidence now. If you are willing to take on new challenges based on the career you have built, we are waiting for applications from you.
Medical Health Service Division/PAL Certification Group
The Pharmaceutical Affairs Certification Department of the Medical Health Service Division (MHS Division) has approximately 10 regulatory application evaluators (Pharmaceutical Affairs Certification Auditors, PAL Assessors) at the Tokyo Headquarters and Kansai Office, divided into the active medical equipment team and the non-active medical equipment team. The organizational structure is relatively flat, probably because it is a foreign-affiliated company, and it is an environment where it is easy to exchange opinions regardless of hierarchy.
●Specific business content
Document evaluation work for the Pharmaceuticals and Medical Devices Act / Manufacturing and Sales Certification Application. We are also engaged in QMS document surveys. After joining the company, you will be certified with an in-house qualification after attending classroom lectures and OJT training. It often takes about a year to qualify, but with the support of experienced senior employees, you can gain solid experience through practical work during that time. After that, as a regulatory application evaluator, you will examine the application form and related materials submitted by the customer, identify deficiencies, complete the examination by requesting the customer to make corrections, etc. It is a series of flows and one project takes about three to four months. We are in charge of about 20 projects/month per person. Divided by active / non-active team, projects are assigned to different smaller groups within each team or are handled individually.