Digital transformation is the future of the pharmaceutical industry. Having an electronic quality management system (eQMS) in place means better efficiency, convenience, and compliance. However, the transformation is not a simple thing as it is a critical change for the quality system.

So why should you go through it and how to do it correctly?

In this episode, my guest is Doron Sitbon, the CEO of Dot Compliance, a company that provides an eQMS solution for pharma, and he is going to answer those questions and much more. 

Here are some of the topics we have discussed: 

💡 Why companies should commit to digital transformation

💡 The challenges and the benefits of a digital transformation

💡 What types of eQMS are there and how to choose the right one for you

💡 How to successfully implement an eQMS in your company

The pharmaceutical industry is very lucrative and offers many employment possibilities. However, finding the right position for starting or advancing your career may present itself as challenging.  

To help you with your job, Matthew Lancaster shares valuables information that will help you navigate this challenging industry and maximize your career achievements.   

Matthew is the Director of Quality & Regulatory recruitment at Life Science People.  

Here are some of the topics Matthew Lancaster and Yan Kugel discussed in this episode: 

💡What is the main reason people fail at job interviews 

💡Which are the hottest position in the industry 

💡What to do if you didn't get the job you wanted  

💡Where in Europe it is easier to find your first job in pharma 

💡Why you SHOULD become a Qualified Person (QP) 

💡Should you, or should you not stay in one company for many years 

In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor.

Jennifer talks and gives practical advice on how to perform a successful supplier or internal audit from start to finish. 

Here are some of the topics we covered in our talk:

💡01 Secrets to a Successful Audit Opening Meeting

💡02 Here Is When Repeated Deviations Are Acceptable

💡03 Why Time Good Time Management Skill Is Important for Auditors

💡04 Here Are the Most Common Mistakes That Companies Do-

💡05 Here Is an Important Message for Auditees-

💡06  How to Write a Good and Useful Audit Report

💡07  This Is Why Audit Trends Are Important-

💡08 How to Become a GxP Auditor

💡09 Here Are the 3 Qualities of a Good Auditor

Jennifer served as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant with expertise in GCP/GVP/GMP/GDP.

In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor.   

Here are some of the topics we covered in our talk: 

✅The Art Behind Being a Great Auditor 

✅The Biggest Challenges of an Auditor 

✅Why Companies Should Be Here Is Why Companies Should Be Happy to Be Audited 

✅The Best Thing About Auditing 

✅Why the Opening Is So Important for a Successful Audit 

✅Knowing the Scope Is the Foundation of the Audit 

✅The Most Common Mistakes of Audit Preparations-

✅Expert Tips for Junior Auditors on How to Learn Their Standards

Jennifer served as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant with expertise in GCP/GVP/GMP/GDP.

The manufacturing of sterile drugs is a critical and essential process. For the process to conform to the strict GMP requirement, it is crucial to design every aspect of the manufacturing with high quality in mind.

In this episode, Ashwani Tripath, head of compliance at Alembic Pharmaceuticals, explains what’s important to take into consideration when designing new aseptic manufacturing.

Here are some of the things you will learn from watching or listening to the episode:

Working in the pharmaceutical industry has its perk, as there are countless opportunities for career advancement. However, finding the right opportunities in the vast GMP world can be challenging. Therefore, having the right headhunter on your side can be highly advantageous.

Yet, not every headhunter is an excellent recruitment consultant. Dealing with the bad weeds can waste you a lot of time, leading to nothing, but dealing with a good one, can land you the gig of your dreams.

Matthew Lancaster is Head of Quality & Regulatory Pharma recruitment at EPM scientific. And in this podcast episode, he is going to explain to us:  

02:35 - What Is the Role of a Good Headhunter in Pharma  

13:41 - How Collaboration With Good Headhunters Can Benefit You  

18:51 - Why Recruiters Should Be More Transparent and Honest  

26:10 -  How to Recognize a Serious Headhunter  

40:13 - What Are the Hottest Positions in the Pharma Right Now  

42:27 - What Impact Did the Coronavirus Have on the Recruitment

You can watch the full video here

Building a successful career in pharma is complicated and requires specific tools, knowledge, and traits. But you can do it with any educational background if you have a healthy hunger for knowledge.

Jennifer Kussauer studied communication. Nonetheless, she built a fantastic pharma career and functioned as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant.

In this podcast episode shares how she managed to build a great career without scientific education. We also dive into the fascinating world of GXP audits.

The full video of our talk will be available from Monday 08.06.2020 on www.qualistery.com.

Today, most experienced pharmaceutical professionals want to become quality auditors, but they are not guided well or not having that much information about how to do it.

By listening to this podcast, featuring Shoab Malek, you will have a clear idea about the role of GMP Auditor, how to become a one,  the challenges, tips, and much more.

Shoab Malek is an experienced & professional Pharmaceutical Consultant and GMP Auditor. He has faced many regulatory audits, which include USFDA, EU-GMP, PICs, UL Registrar LLC (USA), and 100+ vendor audits across India, China & Egypt.

China is the most crucial supplier of chemicals to the pharmaceutical industry because it is not easy to find the alternatives that they have to offer. But there is a lot to consider when sourcing from China. But you have to do a lot of homework.  

Oliver Rhode is the CEO of XENOPS Chemicals and an expert on raw material sourcing from China for the pharma industry. In this episode, he shares his secrets to success in finding the right suppliers in China.

Watch the video on qualistery.com

Proper time management is essential for every worker in the pharmaceutical industry because many of the processes have strict deadlines. Not finishing tasks on time may lead to non-compliance.

In this episode, Yan Kugel talked to Paul Palmer about time management tools and methods, which can help people complete their tasks much more efficiently and promptly.

Watch the video on www.qualistery.com from May 18th.