Contract Clinical Quality Assurance Spain - - Spain
What is the vacancy about
Responsible for the Clinical Quality Assurance Auditors functions of the organization reporting to the Director of Quality Assurance. Ensuring planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of studies conducted at Client Clinical. Lead a team focusing on continuous improvement projects using approved tools, design control, validations, and ensuring adherence to the agency regulations, GxP, Industry Guidelines, local regulations, along with Client Clinical policies and procedures for the conduct of clinical trials. This involves working closely with Clinical Operations, and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities.
Essential Duties and Responsibilities:
· Develop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials conducted at Client Clinical.
· Actively lead or assist activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, and Quality Audits.
· Lead auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, agency regulations.
· Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable.
· Assist with management of contract auditors.
· Assist in conducting vendor audits and work with vendors and production support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves.
· Assist in providing training to Clinical staff.
Long term experiences in Quality Assurance.
MZD is specialized in providing freelance Clinical Research Professionals to the Pharmaceutical and Medical Device Industrie. The freelancer is going to work under our contract for our client. Our client is a global leader in the healthcare business.
The remuneration is based on a hourly rate basis.