Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet Alexis O’temro, Associate Director, Critical Quality Attributes
What do you do at ProPharma? How does your role support improving the health and safety of patients?
The Quality & Compliance field offers a diverse range of responsibilities. As a Qualified Person in the UK, I am involved in ensuring that medicinal product batches are manufactured and tested according to the product license. Additionally, I am one of the named QPs on ProPharma's UK Manufacturers and Importers Authorisation (MIA), enabling us to import and certify products on behalf of clients. My expertise in auditing allows me to conduct audits for clients, ensuring that their suppliers are adhering to the appropriate GMP standards. I have also worked with companies to address compliance issues and support them in returning to a state of compliance, while assisting new companies in developing their quality systems and applying for licenses.
What is one lesson you've learned in this industry that has most helped you?
The implementation of a quality management system cannot be standardized as there is no universal approach that fits all industries. In my experience as an auditor and a Qualified Person, I have encountered various compliant approaches designed to meet the GMP requirements. The needs of a QMS may significantly differ depending on the size and complexity of the operations
What do you like best about working with clients?
I find the variety in my work at ProPharma enjoyable. My clients come from diverse areas within the pharmaceutical industry, offering a wide range of products and services. I have also traveled to various countries to conduct audits and assessments, gaining valuable experience in dealing with different cultures and regulations. It's crucial to tailor my approach to meet the unique needs of each client, taking into account the size and complexity of their operations, whether they have a small team or a large workforce.
Describe the biggest challenge facing our clients/industry today. How are we addressing this?
The industry is currently facing numerous challenges, including the continuous need to maintain appropriate oversight of the supply chain. This has become increasingly complex with the outsourcing of manufacturing and production. The COVID pandemic and resulting travel restrictions have further compounded the issue, leaving many companies struggling to fulfill their obligations. Fortunately, ProPharma has a team of experienced auditors located globally who are equipped to provide support and assistance to companies in need. Our team of local experts also helps to reduce travel time and expenses.
What's one thing you'd like for potential clients to know about ProPharma?
ProPharma distinguishes itself from other consultancies with its extensive range of capabilities and global reach, providing clients with comprehensive support for diverse and complex projects from a single source. Furthermore, our company holds licenses that allow us to import and QP certify products not only in the UK but also in the EU, further expanding our ability to meet clients' needs.
