QA Scientist for GLP

Kymos-Group; Barcelona; Presencial; EUR 42.000 - 66.000; Jornada completa

Descripción de la vacante

Kymos-Group is seeking a Quality Assurance Scientist to join our GLP area of the Quality Assurance Department in Barcelona. You will oversee documentation related to analytical activities and ensure compliance with GLP/GCP standards.

The role involves auditing documents, participating in self-inspections, managing deviations and CAPA, supporting client audits and regulatory inspections, and driving continual quality improvements across the company and subcontractors.

Formación

• Experience in GLP/GCP quality systems and regulatory compliance.
• Ability to review protocols, reports and SOPs.
• Strong audit and CAPA management skills.

Responsabilidades

• Review and approve documentation involved in the analytical activity: protocols, reports, SOPs, raw data.
• Audit analytical documentation to ensure compliance with GLP/GCP regulations.
• Participate in the QA Annual Program of self-inspections.
• Verify the conformity of quality controls in the company’s processes.
• Manage deviations, incidents, CAPA and Change Controls impacting GLP compliance.
• Collaborate in client audits and support regulatory inspections.
• Contribute to the implementation and improvement of quality for the company and subcontractors.

Descripción del empleo

We are hiring a Quality Assurance Scientist for our GLP area of Quality Assurance Department.

The QA Scientist will be assigned the following responsibilities:

• Review and approve the documentation involved in the analytical activity of the company: protocols, reports, SOPs, raw data.
• Auditing the analytical documentation issued by the operative area to ensure the compliance to the internal and external standards according to GLP/GCP regulations.
• Participate in the QA Annual Program of self-inspections.
• Verify the conformity of quality controls established in the company’s processes.
• Management of deviations, incidents, CAPA and Change Controls that impact compliance with GLP principles.
• Collaborate in audits carried out by our clients and give support in the inspections of regulatory authorities.
• Participate in the implementation and improvement of the quality of the company and subcontractors.