Quality Assurance Officer for Clinical and PV

Mission

Overseeing and ensuring compliance with Ferrer's internal procedures, GCPs and GVPs in all assigned areas of responsibility, incorporating continuous improvement initiatives into the Quality System.

Responsibilities

General functions / Responsibilities

Quality Assurance Officer for Clinical and PV is responsible for:

• Draft and review documentation related to their scope of application, including Plans, Risk Assessments, SOPs, or other controlled documents for the performance of duties within the Quality Assurance department, and ensure they are up-to-date.
• Define, develop, implement, and monitor the Key Quality Indicators (KQIs) to measure the proper functioning of the Quality System. Ensure the KQIs implementation.
• Participate in change control, ensuring traceability and proper implementation of these changes in compliance with data integrity practices.

Specific Functions / Responsibilities

Quality Assurance Officer for Clinical and PV is specifically responsible for:

• Ensure initial and ongoing training in GCPs and GVPs. Manage training for the department through the Training Matrix.
• Oversee the Document Management System within the scope of application (GCPs and GVPs).
• Participate in the investigation of Quality deviations and non-compliances, including the management of CAPAs resulting from such deviations.
• Maintain and implement the risk base analysis for the Audit planning of GCPs and GVPs.
• Perform the qualification/approval and periodic monitoring of Clinical Development
  Service Providers (CROs, vendors, etc.) at the corporate level.
• Plan, schedule, conduct, and report on Clinical Development audits (GCP audits), and Pharmacovigilance (GVP audits), acting as lead auditor and/or co-auditor.
• Manage the quality system for internal and external audits and inspections; track and monitor the status of observations and their corresponding CAPA corrective actions.
• Act as support for closure by monitoring preventive and corrective actions in the Clinical Development and Pharmacovigilance area and evaluating their effectiveness.
• Share and/or escalate audit and inspection findings and learning with relevant functional units and management.
• Prepare and support external audits and inspections in the Clinical Development and Pharmacovigilance area.
• Act as advisor between/with functional units and collaborators to promote standardization, improve communication, and enhance the efficiency of quality systems through cooperation.
• Act as an advisor on issues related to the quality system, regulations, GCPs, GVPs and regulatory compliance.
• Contribute to strategic company and Product Development projects. Coordination, execution, and reporting of Due Diligences.
• Participate in different Clinical Research projects that affect or may affect GCPs compliance.

Why Ferrer?

• Make a positive impact in society
• Participate in volunteering activities
• Grow in a culture of trust, responsibility, and constructive feedback
• Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
• Make a real difference to the team and to yourself
• Take advantage of opportunities for development & learning
• Discover a range of benefits to support your physical, emotional and financial wellbeing
• Customize your remuneration and benefit