Quality Assurance Technician (Qa Food)

Pivotal; Madrid; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading contract research organization in Madrid is seeking a Senior Quality Assurance Technician to ensure compliance with quality standards in clinical research. The role requires at least 3 years of quality assurance experience and involves maintaining the QA system, organizing audits, and providing training. The organization offers flexible work schedules and career growth opportunities within a supportive environment.

Formación

• At least 3 years of experience in a Quality Assurance department.
• Alternatively, 5 years supervising clinical trial projects.
• Experience with international projects recommended.

Responsabilidades

• Maintain the Quality Assurance system with the QA&C Manager.
• Ensure GCP compliance and promote quality principles.
• Provide GCP advice to staff involved in clinical activities.
• Organize and participate in contracted audits.
• Track and follow up on audit actions.

Conocimientos

Quality Assurance

GCP compliance

Process improvement

Fluency in English

Microsoft Office

Descripción del empleo

Pivotal is excited to expand our team and is looking for an experienced, highly motivated Senior Quality Assurance Technician who shares our vision of providing clinical research excellence.

Joining Pivotal as a Senior Quality Assurance Technician means becoming part of one of the leading full-service contract research organizations in Europe with a solid reputation. This role offers direct experience with our clients, career growth, and professional development within a scientific and data-driven environment. We prioritize employee care, providing ongoing mentoring, training, and international experiences to support your growth.

The Senior Quality Assurance Technician will support the Senior Manager, Quality Assurance and Compliance (Sr. Manager, QA&C) in quality assurance activities, ensuring compliance with ICH / GCP standards and international regulations across processes and projects.

Key Responsibilities:

1. Maintain the Quality Assurance system in collaboration with the QA&C Manager.
2. Ensure GCP compliance and promote quality principles throughout the company.
3. Provide GCP advice to staff involved in clinical study activities.
4. Assist in process improvement initiatives.
5. Organize and participate in contracted audits (investigator sites, trial master files, databases, ICFs, etc.).
6. Track and follow up on audit actions until resolution.
7. Prepare for sponsor audits and inspections.
8. Maintain and update the Quality Manual and related documents.
9. Provide internal training on quality topics as needed.
10. Oversee computerized systems validation activities to ensure compliance with GxP and data integrity requirements.
11. Track SOP deviations and quality issues, providing QA support across departments.

Minimum Qualifications:

• At least 3 years of experience in a Quality Assurance department within clinical trials, CRO, or pharmaceutical companies.
• Alternatively, a minimum of 5 years supervising clinical trial projects, processes, and procedures as a LCRA or Project Manager.
• Experience with international projects is highly recommended.
• Fluency in English.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

We support flexible work schedules, provide therapeutic training, and foster a collaborative environment to help you succeed and grow in your career.