Job DescriptionClinical Quality Senior Auditor – Cambridge - Permanent
A new role has come available for an experienced Quality Auditor to join an exciting Contract Research Organization in the UK. They are a leader in their market supporting Pharma, Biotech and Medical Device companies and are seeking a Senior addition to their Quality Assurance team.
Senior Quality Auditor Responsibilities:
- Set up, management and reporting of the Quality Audit Programme, ensuring it is followed and kept up to date
- QMS management and reporting as well as computer system validation
- Involvement in and reporting of QMS CAPAs
- Production of the monthly QA report to management using QA metrics and escalate any issues for concern to the Head of QA
- Trend analysis using QA metrics
- Produce training documentation relating to quality and regulatory areas.
- Assist in the management, training and mentorship of our team of QA auditors and provide guidance on internal and external audits
- QA Auditing experience in a regulated environment
- Clinical GCP QA experience
- Experience interacting with regulatory agencies
- Experience in the management of documents (Policies, SOPs etc.)
- Demonstrates leadership ability, communication, and facilitation skills
- Be able to work on own initiative and able to function independently or as part of a team
If you are interested please apply or contact Max at +44 (0) 161 942 4010 or firstname.lastname@example.org for more information.