Quality Assurance Officer of GCPs for Clinical Development
Join to apply for the role at Ferrer as a Quality Assurance Officer specializing in GCPs for Clinical Development.
Mission
The Quality Assurance Officer will oversee and ensure compliance with Ferrer's internal procedures and GCP in all assigned areas, driving continuous improvement within the Quality System.
Responsibilities
General functions :
Draft and review documentation such as Plans, SOPs, and controlled documents, ensuring they are current.
Develop, implement, and monitor quality indicators (KQIs) to assess the effectiveness of the Quality System.
Participate in change control processes, ensuring traceability and proper implementation in line with data integrity practices.
Specific GCP Functions :
Ensure initial and ongoing GCP training, managing the training through the Training Matrix.
Oversee the GCP document management system.
Investigate GCP deviations and non-conformities, managing CAPAs.
Maintain and implement the Clinical audit strategy based on risk analysis.
Qualify and monitor Clinical Development Service Providers, including CROs and vendors.
Plan, conduct, and report GCP audits as lead or co-auditor.
Manage the quality system for audits and inspections, tracking observations and CAPAs.
Support closure of findings by monitoring preventive and corrective actions.
Share audit findings with relevant units and management.
Prepare for external audits and inspections.
Advise on quality system, regulation, GCP, and compliance issues.
Contribute to strategic projects and due diligences.
Manage the Preclinical Research Quality System, focusing on SOPs, supplier approval, and GLP audits.
Why Ferrer?
Make a positive societal impact
Participate in volunteering activities
Grow in a culture of trust and responsibility
Enjoy flexible work and collaborative environment
Opportunities for development and learning
Benefits supporting wellbeing
Customize remuneration and benefits
Requirements :
What You'll Need To Succeed
Empathy, humility, curiosity, and optimism are key qualities.
Adecuado candidate profile:
Degree in life sciences or healthcare (pharmacy, biology, medicine)
GCP and pharmaceutical QA training
Master's in Clinical Trials (highly valued)
Over 5 years experience in GCPs or equivalent
Experience in GxP activities (QA, GCP auditing, clinical development)
Advanced English skills
Knowledge of GVPs, GLPs, CSV
Ability to work independently as a GCP auditor
Project management skills in clinical development
If this challenge matches your profile, we look forward to your application!
Ferrer guarantees equal opportunity, assessing candidates based solely on skills and experience.
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