Senior Auditor, GMDP, Biotech, Cambridge
Senior Auditor, GMDP, Global BioTech – Cambridge(Other titles include: Senior Quality Assurance Auditor, Senior QA Auditor, Senior Quality Auditor, Senior GMDP Auditor, Senior GMP Auditor, Senior GDP Auditor)Skills Alliance have partnered with an innovative global Biotech to support the build out of a brand new dedicated audit function that will ensure compliance to GMP and GDP standards within their complex, global network of internal and external affiliates across multiple therapeutic areas and supporting various projects across the business (due diligence, new product introduction etc).Company OverviewOperating as a network of companies this global Biotech has a proven track record of developing, marketing and manufacturing pioneering products across multiple therapeutic areas over the course of the last few decades. Whilst they are consistently expanding they maintain a highly collaborative working environment and culture. This continuous but scalable growth contributes heavily to the professional development opportunities within this organisation that is simply unrivalled elsewhere in the industry. Recent growth has necessitated the development of a new dedicated audit function that is responsible for planning and executing the global GMDP audit programme.Role OverviewAs one of the first hires into this new, dedicated function the Senior Auditor (GMDP) will take responsibility for their own audit scheduling, planning and execution with full autonomy to manage the end-to-end life cycle of audits. This audit schedule covers almost every dosage form and therapeutic area including everything from Solid Dose to Biologics facilities and Medical Device manufacturers. In support of the wider business you will also contribute to projects such as due diligence and new product introduction. As this is a new department there is also the opportunity to take a central role in the development of processes and best practice as well as hiring, training, mentoring and developing more junior auditors as the team grows.Required Skills and ExperienceSignificant experience in carrying out both GMP and GDP audits is essential, as is strong inter-personal skills and the capability to influence which more experienced auditors will have developed over experience. Those with experience on Biologics and Medical Device sites would be particularly well suited to this department although this is not essential and training can be provided to those without this. Previous experience of training or mentoring junior auditors would also be preferred. In return this person will get the opportunity to work in a new function and exposure to a diverse and challenging working environment and a highly competitive and comprehensive remuneration package. If you would like to be considered for this opportunity, please click APPLY to send a copy of your CV. For further details and a full job description, please call Joshua Godden on +44 (0) 207 220 6224 or e-mail Joshua.Godden @SkillsAlliance.com. All inquiries are treated confidentially.