Quality Assurance Manager - Clinical Trials or Healthcare
Title: Quality Assurance Manager - Clinical Trials or Healthcare
Location: London , City
Salary: To GBP 55k plus benefits
The Quality Assurance Manager will be part of the clinical data team and will be responsible for establishing and managing the organisation's Quality Assurance functions, ensuring that compliance standards and customer expectations are met.
Duties and responsibilities
* Establish and develop a quality assurance framework for the company and it's major projects
* Manage all key quality functions risk assessments, Corrective And Preventative Actions (CAPAs) and process change
* Support the development of mission critical controlled processes and ensure staff comply with these defined processes. This will include authoring and reviewing of standard operating procedures (SOPs) and regular quality reports.
* Identify quality risks within the programme, develop mitigation plans and monitor their effectiveness.
* Maintain an effective document control system.
* Prepare and conduct internal process review and external audits. Take responsibility for delivery of any CAPAs that result.
Essential skills
* Demonstrated commitment to quality
* Proven experience of quality management systems and implementing process improvements and supporting staff with process development and documentation.
* Familiarity with clinical research and the NHS.
* Demonstrable experience of using and implementing CAPA systems.
* Experience of planning and conducting audits.
* Experience of writing Standard Operating Procedures.
* Experience of conducting risk assessment and developing risk based monitoring plans.
* Experience of applying industry standards in a pragmatic value added way
* Degree level qualification, or equivalent, in a medical science or relevant discipline.
Location: London , City
Salary: To GBP 55k plus benefits
The Quality Assurance Manager will be part of the clinical data team and will be responsible for establishing and managing the organisation's Quality Assurance functions, ensuring that compliance standards and customer expectations are met.
Duties and responsibilities
* Establish and develop a quality assurance framework for the company and it's major projects
* Manage all key quality functions risk assessments, Corrective And Preventative Actions (CAPAs) and process change
* Support the development of mission critical controlled processes and ensure staff comply with these defined processes. This will include authoring and reviewing of standard operating procedures (SOPs) and regular quality reports.
* Identify quality risks within the programme, develop mitigation plans and monitor their effectiveness.
* Maintain an effective document control system.
* Prepare and conduct internal process review and external audits. Take responsibility for delivery of any CAPAs that result.
Essential skills
* Demonstrated commitment to quality
* Proven experience of quality management systems and implementing process improvements and supporting staff with process development and documentation.
* Familiarity with clinical research and the NHS.
* Demonstrable experience of using and implementing CAPA systems.
* Experience of planning and conducting audits.
* Experience of writing Standard Operating Procedures.
* Experience of conducting risk assessment and developing risk based monitoring plans.
* Experience of applying industry standards in a pragmatic value added way
* Degree level qualification, or equivalent, in a medical science or relevant discipline.