QA to QP – A Natural Progression?
I samarbete med Apotekarsocieteten och Prudensa In collaboration with Apotekarsocieteten and Prudensa Consulting, SallyQ invites you to a seminar series on manufacturing and quality in a changing world!
On four occasions, we highlight different aspects of the theme Manufacturing and Quality in a Changing World, with the aim of strengthening the QA profession and creating the conditions for the right quality level and cost-effective pharmaceutical manufacturing. During the second session, which took place in December 2024, we addressed the journey between QA and QP under the title 'QA to QP – a Natural Step?
Below are 5 lessons
- Be brave enough to challenge the regulations.
If you do not meet all the formal requirements to become a Qualified Person (QP), do not be afraid to argue with the Swedish Medical Products Agency (Läkemedelsverket). Highlight all the relevant experience and expertise you have gained throughout your career. There are more than one way to become a QP. - Personal qualities are crucial.
To succeed in the role of QP, you need to develop qualities such as determination, composure, and the ability to clearly explain and justify your decisions. These abilities are just as important as technical knowledge. - You are part of a team.
Även om rollen innebär stort ansvar och utmaningar, står du aldrig ensam. Du är en del av ett team där du kan diskutera svåra frågor och dela beslutsunderlag. Du behöver inte veta allt – fokus ska ligga på att samla och analysera information för att fatta informerade beslut. - Network and seek mentorship.
Being new as a QP can be overwhelming, but support is available. Build a network, ask for help, and find a mentor who can share their experiences and provide guidance. - Humility and a lack of arrogance are key.
Decisions are always made based on the information available at the time. If it later turns out that a decision was incorrect, be clear about why you made the assessment and learn from the situation. An unpretentious attitude is crucial for success in the role.
The role of a QP is both challenging and enjoyable, and it presents an opportunity to make a difference in an exciting industry!