Quality Assurance Officer of GCPs for Clinical Development

Ferrer; Barcelona; Presencial; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Barcelona is seeking a Quality Assurance Officer to ensure compliance with GCP for clinical development. The role involves monitoring quality indicators, managing audits, and implementing quality systems. Ideal candidates will have a degree in life sciences, over 5 years of GCP experience, and strong project management skills. Join us to make a positive societal impact and grow in a collaborative environment.

Servicios

Flexible work environment

Opportunities for development and learning

Benefits supporting wellbeing

Formación

• Over 5 years experience in GCPs or equivalent.
• Experience in GxP activities (QA, GCP auditing, clinical development).
• Ability to work independently as a GCP auditor.

Responsabilidades

• Oversee compliance with internal procedures and GCP.
• Draft and review documentation such as Plans and SOPs.
• Conduct GCP audits and oversee deviation management.

Conocimientos

GCP knowledge

Pharmaceutical QA training

Project management skills

Advanced English

Educación

Degree in life sciences or healthcare

Master's in Clinical Trials

Descripción del empleo

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.

Ideal 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.