Quality Assurance Associate GCP (m/w/d)
EUR50000 - EUR60000 pro Jahr
Your Role:
You are responsible to support the development, implementation, maintenance, and monitoring of Quality Management Systems (QMS) and activities in the execution of Quality Assurance deliverables. You are supporting the Quality Assurance department, through assisting with audit activities in support of ongoing quality improvement. You act as a liaison with other business units and partners and assumes some responsibilities for Quality led initiatives, based upon knowledge of regulations, standards, and industry best practices.- Assist in the management of GCP quality systems which include the following:
- Oversight of Standard Operating ProceduresUpdates to current and development of new SOPs
- Management of SOP training programme
- Implementation of systems to assess compliance with SOPs and facilitate improved compliance where necessary
- Assist the management of Work Instruction documentation
- Review internal records (e.g. employee training records, study files, etc) for compliance with SOPs and applicable regulations, guidelines, and ITM policies
- Facilitate implementation of non-QA document and data review process to ensure compliance while maintaining efficiency
- Provide GCP compliance advice and guidance to team members to achieve continuous quality improvement
- Assist internal GCP inspection readiness activities to prepare for clinical sponsor inspection, investigator site inspections
- Assist with development, implementation, and maintenance of robust and proactive GCP quality management system, including development of standard operating procedures and work instructions related to clinical research conduct
- Stay up-to-date with new and revised regulations and trends in industry standard
- Serve as a GCP subject matter expert and provide compliance guidance to internal employees
- Assist with establishment of training procedures, development of functional area training matrix and documentation of training
- Track training compliance of clinical functional areas and provide quarterly training metrics to Quality.
- Maintain required knowledge of applicable regulations and government, industry and company GCP standards and their interpretations by participating in industry trainings, workshops and discussion groups
- Support the development and delivery of GCP training programs
Quality Assurance Associate – GCP (m/w/d) (BBBH597259)
mehr...zur Vakanz
Weitere Jobs von Aplitrak