Senior QA Executive
Jim Gleeson is recruiting for a Senior Clinical QA Executive to join an innovative and highly successful biotechnology company developing novel treatments for neurological disorders. The role will be primarily home-based though you will need to visit the Cambridge office for two or three days a month.
As Senior Clinical QA Executive you will prepare for, execute, report and follow up a wide variety of audit types to ensure that clinical development activities comply with company requirements, local regulations and ICH-GCP requirements.
Key duties will include:
- Planning, execution and follow up of Investigator site, vendor, documentation, pharmacovigilance and internal system audits
- Reporting and presenting to clinical staff, Investigators and other hosting company personnel on potential findings identified during audits
- Assisting the CQA Officer with the tracking of audit CAPAs that they're resolved and closed-out appropriately and in a timely manner
- Provision of support to the clinical development function, contributing to SOP development and advising on processes and audit preparation
- Representation of the QA group at relevant meetings
As Senior Clinical QA Executive you will require the following:
- A relevant BSc
- Strong GCP experience gained in a pharmaceutical company or CRO
- A background in GPvP would be advantageous
- Proven experience of auditing internal activities, Investigator sites, third party vendors, documentation and databases
- Willingness to travel throughout the EU as necessary
- Excellent interpersonal and communication skills
For more information or to apply for this position, please contact Jim Gleeson on 01438 842973 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46737 in all correspondence.