Our client is a leading Global Clinical Research Organisation specialising in drug, diagnostics and medical devices development.
* Are the world's second largest provider of late phase services.
* Have an excellent reputation in the Pharmaceutical industry for a range of therapies including Oncology and Genomics.
* Have obtained a number of high-profile awards for their work.
Our client is looking for a Senior GCP Auditor to join their QA team. This is a home-based role with around 35% domestic and international travel required. Responsibilities of the role include;
* Effectively Plan and conduct QA audits in order to assure that clinical studies are of the highest standard and are in compliance with requirements company and Sponsor Standard Operating Procedures, study protocols and relevant regulations.
* Maintain a thorough knowledge of all relevant company SOPs, Good Clinical Practice guidelines, relevant regulations and ISO requirements.
* Perform quality system audits and process, supplier/vendor audits and contract audits for Sponsor companies
* Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented.
* Train and mentor new QA auditors in order for them to perform their function effectively and provide a benchmark of auditing competencies to less experienced colleagues.
* Liaise with clients and project managers on quality aspects of studies including the attendance at meetings, oral presentations and audits
* University/Bachelors' degree or local equivalent in medicine, science or equivalent degree/experience
* Extensive experience in Quality Assurance auditing.
* Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.
* Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
* Ability to successfully implement quality plans for all phases of a trial.
* Good commercial awareness and customer focus.
* Detailed understanding of drug development and clinical trial process.
* Good planning and organizational skills with the ability to multi-task and prioritize effectively.
* Cost consciousness.
* Ability and willingness to travel at least 35% of the time (international and domestic)
What should you do next?
This Senior GCP QA Auditor role is one not to be missed; it encompasses the opportunity work for an exciting, forward thinking company……..To discuss further, please submit your current CV.
Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.