Senior QA Auditor – CRO – Remote UK – Up to £45k flexible DOE
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
They are looking for an experienced Senior Auditor to join their European QA Auditing team in the UK.
- Plan and conduct regular internal audits as well as contract audits (including standalone work) in order to evaluate the quality system against the requirements appropriate regulations and applicable guidelines.
- Perform the role of a lead auditor to assess the effectiveness of the quality system and to verify that the quality system is being implemented.
- Perform vendor and sub-contractor audits and follow up of previous findings, as well as validation reviews as required.
- Review audit replies to Q&C. Follow up all outstanding replies and report issues to the relevant management for action.
- Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.
- Assist with the development of the project audit schedule.
- Verification of audit CAPA completion where required by procedure.
- Train QA auditors, and provide a standard for auditing to inexperienced or less experienced colleagues.
- Carry out a senior role in the regional QA department (Project Audits), such as scheduling of audits. Operates under moderate supervision and direction and makes decisions frequently that have a direct impact upon the local external and internal audit schedule and the resource allocation for audits within the local department.
- Background in medicine, science and/or other relevant discipline and appropriate experience.
- Must have 3 years’ experience within QA auditing in the UK
- Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.
- Knowledge of CAPA management, including performing effective root cause analysis
- Experience in regulatory authority inspections an advantage
- Knowledge of medical Device (MDDR) an advantage
- Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
What should you do next?
This Senior QA Auditor role is one not to be missed; it encompasses the opportunity to work within a highly reputable global CRO. 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.