Duration
- Till end of the year, option to extend at year end
Description
- Our client has a need for a GCP/QA Contractor to join the team at their facility. The ideal candidate would have 5+ years of experience and 1+ years of GCP or CQA experience. They would be responsible for assisting with clinical trials, handling basic GCP activities, managing documentation, and a plus would be background or understanding of regulatory authority inspection.
Purpose of the role
- Act as the primary clinical quality contact for entities or individuals involved in clinical trials conduct
- Support and oversee the quality event/ Serious breach management
- Support and oversee the CAPA management activities
- Support the inspection readiness activities
- Support audits activities
Duties and Responsibilities
- Clinical study QA representative
- For the clinical studies assigned, works with the study team to ensure good clinical practices and compliance to the relevant regulatory requirements are met
- Participate to project meeting and ensure timely assistance for all quality related topics
- Participate to service provider selection and quality oversight for the studies assigned
- Escalate to QA TA Lead identified issues that require further support and assistance
QMS Process
Quality Event and Serious Breach
- Review and approve major/critical Quality Events and potential Serious Breaches
- Corrective and Preventive Actions (CAPA):
- Support business functions, and tracking to timely completion, of Corrective and
- Preventive Actions, contributing to root cause and risk analysis of clinical research matters, and assisting in establishing the effectiveness of implemented CAPA.
- Report CAPA status and metrics, escalating any issues regarding delayed timelines or ineffectiveness of CAPA, as needed
- Ensure timely delivery by following up with CAPA owners and scheduling meetings as necessary and facilitating Quality Risk Management activities
Quality Documents
- Contribute to the continuous improvement of R&D Quality Documents as assigned
Quality Assessments
- Contribute to the Quality Assessments/Self-Inspection as assigned
Audits and Inspections
- Support inspection readiness activities for high-risk studies:
- Support sponsor mock inspection, quality assessment activities,
- Conduct the quality control of study documents
- Set up regular meetings with Subject Matter Experts (SMEs) (including Service Provider), workstreams per topics to enable successful preparation outputs/deliverables,
- Monitor progress of the preparation of the inspection and report the risks identified, any remediation actions,
- Assist in the preparation and conduct of inspection as required.
- Ensure timely data entry within the eQMS
- Support the audit activities: provide information to audit group for their risk assessment and audit activities, facilitate further investigation of observations (when needed), root cause analysis and definition of CAPA.
Training
- Contribute to training sessions as SME, by reviewing training materials or participating in presentations where needed.
- Guide system users to ensure they are trained when required (e.g. when a specific training task is required in eLMS)
- Liaise with process owners and trainers to ensure appropriate training material is generated and made available for clinical research activities.
Experience & Qualifications:
- Minimum 5 years’ experience in Quality Assurance in the pharmaceutical industry in management of quality system including experience at corporate level preferably in Research and Development
- Language : English
South of Paris, FR: QA Contractor (235194)
