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 QA PV Auditor to join their team in Europe! The role will be mainly homebased with up to 35% travel within Europe for site and client audits. Responsibilities of the role include;
* Effectively Plan and conduct PVQA audits in order to assure that safety related activities managed by the company are of the highest standard and are in compliance with the requirements of Sponsor Standard Operating Procedures and relevant regulations.
* Maintain a thorough knowledge of all relevant SOPs, Good Pharmacovigilance Practice guidelines and relevant regulations.
* Perform quality system audits and process audits.
* Perform supplier/vendor audits.
* Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented.
* Assist with the review of audit reports and audit results, and with performing analyses and trending of audit results, as required.
* Assist with the planning and coordination of specific projects related to the development and Improvement of the company Quality Assurance program
* Perform lead auditor duties assigned in an efficient and effective manner. This includes liaising with the project manager on all QA issues, including audit planning and review of audit results.
* Perform QA Review of SOPs, as required.
* 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 safety related activities including attendance at meetings, oral presentations and audits.
* Assist with business development activities, as required.
* Coordinate or assist with Sponsor audits and Regulatory Inspections, as required.
* Assist with the management of the department when requested including resourcing, assignment of workload, and scheduling and review of audits.
What should you do next?
This Senior PV QA Auditing role is one not to be missed; it encompasses the opportunity to 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.