A Career in Quality Management: Insights from Biocodex Phame

Through 9 years in Biocodex Phame I have had plenty of diverse variety of tasks. My main job responsibilities are related to medicines registration and market access, pharmacovigilance, compliance and quality topics and all tasks related to those responsibilities. I believe that life is a constant learning and self-improvement journey. I graduated University of Tartu as Master of Pharmacy. For a little while ago I decided to take next step and fulfill my knowledge in Tallinn Economics School speciality in quality management. This combination of knowledge and experience from my job gives me a strong background to be more efficient and productive in my professional life. In addition to Biocodex Phame my work experience is acquired also in general pharmacy, regulatory authority and consultancy company.

In Biocodex Phame the most surprising is that there are always new interesting projects to contribute to and supportive colleagues from different countries sharing their experience with whom to exchange knowledge and best practices.

Furthermore, I like to keep an eye on changes and everything going on with areas I am focused on in local and European Union level and in my free time I enjoy reading new updates and listening trainings and Podcasts.

Pursuing Quality Specialist Studies

Two years ago I made an important change in my life and started with quality specialist studies. This step was interesting but also exciting if it is possible to manage this challenge and how to manage it besides everyday job and family. However, Tallinn Economics School had a very supportive atmosphere providing practical knowledge to use in daily practice. In addition team with whom we shared this journey was very special, enthusiastic and willing to learn.

As every new knowledge opens new possibilities I have had the opportunity to apply principles of quality management, auditing, risk and changes management, standards, continuous improvement etc in my daily work.

For example, I have introduced the possibility to contribute in development of quality management system, I received internal auditor training to perform regular audits for the benefit and improvement of an organization.

Key Responsibilities of Internal Auditors

Internal audits are systematic, independent, documented processes where objective evaluations are conducted within an organization to declare compliance and assess if procedures provide expected results and recommendations to improve procedures.

The most important task for internal auditors is to perform qualification training and practical work as co-auditor. Afterward person can carry on internal audits individually. Auditors perform audits based on their best knowledge, skills and independence (their own responsibility area can´t be audited). General principles are fair representation, professional due diligence, confidentiality, independence, and evidence-based approach.

An internal audits program is created and approved annually. The auditor creates an action plan to perform internal audit, schedules audit time with auditees and determines the scope of the audit.

In addition of good knowledge of the audited area, the main characteristics of the auditor is to create a good and constructive atmosphere during the audit to discuss topics and receive maximum benefit and a clear picture of activities in the scope of the audit.

During the audit auditor collects information and justification and compares it with audit criteria (evidence is evaluated against requirements). Observations are documented and classified. Auditees submit action plans to remove reasons for non-compliance and implement improvements.

Performing internal audits is an interesting and developing process for both sides – auditee and auditors, it is the reason for starting beneficial discussions with colleagues which have been profitable and constructive and ensure continuous improvement of employees and the organization.