Retirement from Service Spanning More Than Two Decades

Ahmad Mohammed Ali Youssef, Advisor to the Chairman & Managing Director is retiring today, the 25th of April 2019 after serving Pharmaceutical Solutions Industry (PSI) for twenty-eight years. After attaining Bachelor and Master of Pharmacy, from King Saud University, Riyadh he started his career at the Central Lab for Drug and Food Analysis, under the Ministry of Health, Riyadh. 

It was during 1991, Dr. Ahmad was appointed as Registration Officer-cum-Senior Lab Analyst at PSI, and his key responsibility was to evaluate product registration files that were delivered to MOH with stability studies.

During his tenure with PSI, from Jan 1991 till Apr 2019, he was designated in several positions, and he carries excellent interpersonal skill and knowledge, which helped completing lot of valuable business assignments with several drug authorities both inside and outside the Kingdom of Saudi Arabia.

What inspired you to leave the job at MOH and join Pharmaceutical Solutions Industry (PSI)?

I was happy working at the Central Lab for Drug and Food Analysis, Riyadh. But due to ailing condition of my father, who was in Madinah, I wanted to be near to him. When I got a good offer at PSI, then without giving a second thought, I left Riyadh and moved to Jeddah. Moreover, being in Jeddah, it was more convenient for me to pay visits to my sick father, as the distance to Madinah, from Jeddah, is less.

Can you tell us something about your first impressions when you joined PSI?

When I joined PSI, the product portfolio was limited without any product registered in the Ministry of Health. At that time, PSI, was in collaboration with the German company Fresenius AG  and was progressing well since it had no local competitor.

Perhaps, I must say, my initial major task that I was assigned was to prepare product registration files, along with the stability studies, and subsequently submit those files to the MOH, Riyadh and follow up with MOH in obtaining product registration certificates. Thereafter, as per the instruction of Dr. Abdulaziz Serafi, General Manager of PSI, I started sending product registration queries to Gulf countries and other Arab countries (such as Egypt, Jordan, Libya and Sudan).

During your initial career at PSI what was your major role and responsibility and how did you progressed over the years?

In addition to product registration responsibilities, I was entrusted with the roles of Quality Assurance manager as well as Management Representative. 

Over the years, I have put in organized efforts, professionalism and required obligations in order to make QA as custodian of the pharmaceutical quality system while recognizing possible gaps and making recommendations for enhancements through respective procedures, standards and specifications.

For a short stint, besides QA Manager, I had held the position of ‘Acting Quality Control Manager’. In 2007, with the formation of Regulatory Affairs Department, I was appointed as Regulatory Affairs Manager, and continued on this post until February 2018. During this period, I have done my best through my valuable contributions, commitments and credibility.

What was your key responsibility with the additional role of Management Representative at PSI?

As a Management Representative I was actively involved in the establishment and implementation of ISO 9001 Quality Management System (QMS) in PSI. I was solely responsible for handling any customer complaints and/or product recalls against PSI, in terms of Quality and Stability Studies.

On the basis of your past experience how would you describe the regulatory affairs in the pharmaceutical industry?

The nature of regulatory affairs department work is same as the work of the Ministry of Foreign Affairs of each country. It interprets and communicates on behalf of the senior management and the company owners for the benefit of pharmaceutical companies in terms of complaints and inquiries, and clarifies the questions asked and also cooperates with sales departments regarding the product registration and problems and requests for the sake of quality and registration. And it sets the date of inspection with the inspectors in coordination with key personnel and requests a visit to clarify some of the technical problems of quality and stability study.

Regulatory affairs department plays a specific role between the various departments and outside the factory from the government officials. It interacts with different departments within a company in order to fulfill regulatory obligations with the health authorities. It keeps itself engaged in all phases of drug development and approval and marketing.

After retiring from PSI what are your main priorities, expectations and ambitions?

It’s plain truth that I haven’t thought anything. May be, if all goes well after this retirement, I would like to render my expertise and skills as a Freelance Consultant.

Would you like to offer any concluding message?

From the bottom of my heart, I would like to give words of advice to one and all to consider PSI as a family and work with integrity and in harmony for the progress and success of PSI.