AlfaNordic’s QA consultants
The quality work has always been a core area within Life Science (pharmaceutical industry, Biotech and Medical Devise) and the requirements have been perceived as being on the rise during the last many years. It is therefore extremely important for the manufacturers that their quality departments work to an optimum within the balance between thoroughness and flexibility, where the foundation is always the legislature in effect at all times as well as cGMP.
QA employees also find themselves in a context with constant changes as optimisations/LEAN are often part of the agenda. At the same time, the rule and regulations in effect are optimised towards heightened quality with consequently increased requirements for the documentation. The GMP rules are continuously under revision and one of the constant change initiatives is that the requirements for risk assessments are continuously increased for new as well as existing products and processes. The results are inherent requirements for and expectations of a proper ”root cause analysis”.
The area of QC and QC Support are seeing comparable changes, and at the same time, the analysis equipment becomes more effective and sophisticated, and validation of analysis methods and equipment consequently make bigger demands on the technical competencies – including knowledge of IT/Automation.