Each pharmaceutical company must ensure that its products are suitable for their intended use, and that they do not endanger the health of patients, due to inadequate safety, quality or efficacy. This is a complex but critical goal, which is ensured by an appropriate Quality System. Anna Boselli, Sr. Quality Compliance Manager at IBSA Group, talks about it in this new interview.
Conversation with Anna Boselli, Sr. Quality Compliance Manager at IBSA Group
CAN YOU TELL US MORE IN DETAIL WHAT THE QUALITY ASSURANCE DEPARTMENT DOES?
Quality Assurance (QA), a department to which I proudly belong, develops and ensures that the entire company and all phases of the process (from research and development to the construction and maintenance of plants and departments, from procurement to storage and production, from quality control to Information Technology) correctly apply the Quality System. More specifically, QA deals with:
- defining the guidelines and internal rules of the Quality System, and training the staff;
- ensuring, through audits and documentary checks, the correct application of the Quality System by all company functions and departments, as well as the quality of third parties (customers, product suppliers, subcontractors, suppliers of activities such as storage and transport, consultants);
- actively participating in audits performed by third parties and in inspections carried out by regulatory and certification bodies;
- ensuring that the application of any changes and the occurrence of any anomaly are correctly managed, in order to define any corrective actions and to assess their impact on the Quality System and the product.
In recent years – also thanks to a continuous expansion of the company – our department has an increasingly international profile. This translates, for example, into inspections conducted by new ministerial authorities, audits to be carried out in new countries, new customers to manage… a prospect that I think is very interesting and stimulating.
HOW DO YOU ABIDE BY IBSA’S FOUR PILLARS – PERSON, INNOVATION, QUALITY AND RESPONSIBILITY – IN YOUR DAILY ACTIVITIES?
These are all fundamental values. Our goal is for the Company to produce Quality: Quality must be our culture. Secondly, the Company is made up of People, who are the primary resources with whom we must interact on a daily basis to ensure that everyone, with their activity, produces Quality. As for Responsibility, it ensures the protection of the patient, that is the final user of what we produce, and is the unavoidable factor with which each of us operates. Last but not least, the company is – and must always be – able to guarantee an excellent level of Quality also through continuous Innovation.
WHAT ARE, IN YOUR OPINION, THE ESSENTIAL QUALITIES FOR EXCELLING IN YOUR FIELD?
First of all I would say expertise, knowledge, information, continuous updating and curiosity, since it is only by knowing and sharing this know-how that it is possible to do an excellent job.
Equally important are, in my opinion, human relationships – knowing how to listen and communicate and having a good persuasive ability help us in our constant interaction with the company, which is made up of people – as well as, of course, respect for others and a good dose of humility.
I also consider very important the ability to know how to focus on critical issues and to put things in the right perspective, and the skill in finding adequate solutions, even with a pinch of imagination.
Finally, experience – for all these characteristics – helps a lot, as well as a great passion for one’s work.