Quality Specialist Manager 16836 (3)
Posted 1 day 4 hours ago by CK Group
Permanent
Not Specified
Healthcare & Medical Jobs
London, United Kingdom
Job Description
CK Group are recruiting for an Quality Specialist to join a leading provider of advanced analytics research and technology solutions to the life sciences industry at their site based in Paddington for two days, one day in Basildon office and two days working from home. London on a contract basis for 12 months.
This role is hybrid.
Salary:
Daily rates depending on experience, please quote
Quality Specialist Role:
Company:
Our client offers research services and technology solutions in the life sciences industry. With just under 100,000 employees, the company has operations in over 90 countries worldwide. Our client s ambitions involve optimising results of innovations using artificial intelligence. They believe in utilising data collected to the maximum rather than focussing on gathering lots of information: they use artificial intelligence to do this.
Location:
This role is a hyrbrid role, it is based at our client s site in Paddington, London and also Basildon.
Apply:
For more information, or to apply for this Quality Specialist please contact the Key Accounts Team on or email . Please quote reference .
It is essential that applicants hold entitlement to work in the UK
Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
This role is hybrid.
Salary:
Daily rates depending on experience, please quote
Quality Specialist Role:
- Ensure that all clinical trials are conducted in compliance with regulatory requirements (EMA, MHRA, JFDA, DCGI etc.), ICH-GCP, and applicable national regulations.
- Monitor adherence to the sponsor company's SOPs, protocols, and standards.
- Plan, execute, and follow-up on clinical site audits, vendor audits, CRO audits, and internal audits.
- Prepare detailed audit reports, identify non-compliance issues, and ensure corrective and preventive actions (CAPAs) are implemented.
- Review and approve clinical trial-related documents, including protocols, informed consent forms, clinical study reports, etc.
- Minimum 5 years of experience in clinical quality assurance in a CRO or pharmaceutical/biotech company.
- Detail-oriented and able to work effectively in a team environment.
- Bachelor's Degree Required
- Knowledge of global clinical trial requirements and guidelines.
- Experience in conducting GCP audits (clinical sites, CROs, vendors, and internal audits).
Company:
Our client offers research services and technology solutions in the life sciences industry. With just under 100,000 employees, the company has operations in over 90 countries worldwide. Our client s ambitions involve optimising results of innovations using artificial intelligence. They believe in utilising data collected to the maximum rather than focussing on gathering lots of information: they use artificial intelligence to do this.
Location:
This role is a hyrbrid role, it is based at our client s site in Paddington, London and also Basildon.
Apply:
For more information, or to apply for this Quality Specialist please contact the Key Accounts Team on or email . Please quote reference .
It is essential that applicants hold entitlement to work in the UK
Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.