QA & Compliance
Quality Assurance is an area which impacts upon all aspects of the life sciences industry and product development. Within Pharma and Biotech Research is conducted under Good Laboratory Practice (GLP), Clinical Development programmes are designed with Good Clinical Practice in mind and the manufacturing of all products are covered under Good Manufacturing Practice. In recent years we have seen an increase in Pharmacovigilanance and Promotional compliance which affects both development projects and marketed products.
In this area we are focussing on Clinical and Pharmacovigilance jobs.
In Europe and the Emerging Markets all Clinical Trials are supposedly conducted to ICH Guidelines which sets out the principals for independent auditing of clinical trials and the development of the Quality Management Systems required to ensure these guidelines are being met. These systems then have to be enforced not only throughout the organisation but also in external organisations such as CRO’s and trial sites. Therefore, as well as possessing good process skills and an eye for detail it is imperative to have good communication and problem solving skills. This is especially true when trying to resolve issues that arisen to ensure the Corrective and Preventative Action Plans (CAPA) are adhered to. With the shift towards risk-based auditing the focus of these roles are becoming more strategic and it is now imperative that QA plans are included in part of the overall Clinical Development plan.
There has been a significant increase in the number of Health Authority Audits (EMA, FDA,MHRA etc.) in recent years as there has been an increased emphasis in Drug Safety of marketed products and therefore a significant uptake in the need for PV auditing. This has been exacerbated by the introduction of a new EU Directive which took effect in July 2012. As a result of this many Life Science companies are moving towards a dedicated GPvP auditing team.
Liftstream has an excellent understanding of both the technical and soft skill sets required to build a successful QA and Compliance team and with its rigorous search process and competency framework is ideally place to provide high quality senior level candidates that drive a culture of compliance and quality throughout an organisation and beyond.