Job description



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 DevelopmentService 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

Requirements



You will rock at this company if you are a person with empathy, humility, curiosity and optimism, and you match with:

Required Studies• University degree in life science or healthcare (pharmacy, biology, medicine...)• Quality Assurance courses in relation to Pharmaceutical Industry.• Specific courses in Pharmacovigilance practices or Master related to Clinical Trials arehigh valuable.
Previous experience• More than 5 years' experience in GxPs in Pharmaceutical Industry or equivalent.• Experience in GxP regulated activities (QA, PV, Clinical dev., CRA, Quality Auditor...)
Languages• English Advanced Level (oral and writing)Other specialized knowledge valuable:• Good Laboratory Practices (GLPs)• Knowledge of computer systems validation (CSV)
Skills• Ability to travel and work independently as GxP auditor• 2 or more years in management of clinical development projects

If this great challenge matches your profile, then we are waiting for you!
At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.