QA Scientist for GMP

Kymos-Group; Barcelona; Presencial; EUR 45.000 - 60.000; Jornada completa

Descripción de la vacante

Kymos-Group is seeking a Quality Assurance Scientist to join our GMP-focused QA Department in Barcelona. The role focuses on ensuring documentation quality and ongoing compliance across analytical activities.

You will review CoA, SOPs, and protocols; audit analytical documentation for cGMP alignment; participate in the QA Annual Program of self-inspections; support regulatory inspections and supplier audits, contributing to continuous quality improvements within the organization.

Responsabilidades

• Review and approve the documentation involved in the analytical activity of the company: CoA, protocols, reports, SOPs, product specifications.
• Auditing the analytical documentation issued by the operative area to ensure the compliance to the internal and external standards according to cGMP regulations.
• Participate in the QA Annual Program of self-inspections.
• Verify the conformity of quality controls established in the company’s processes.
• Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA and Change Controls.
• Review of the Quality/Technical Agreements between the company and subcontractors, especially with regard to batch certification activities.
• Collaborate in audits carried out by our clients or subcontracted manufacturers and give support in the Inspections of regulatory authorities.
• Participate in the implementation and improvement of the quality of the company and subcontractors.

Descripción del empleo

We are hiring a Quality Assurance Scientist for our GMP 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: CoA, protocols, reports, SOPs, product specifications.
• Auditing the analytical documentation issued by the operative area to ensure the compliance to the internal and external standards according to cGMP regulations.
• Participate in the QA Annual Program of self-inspections.
• Verify the conformity of quality controls established in the company’s processes.
• Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA and Change Controls.
• Review of the Quality/Technical Agreements between the company and subcontractors, especially with regard to batch certification activities.
• Collaborate in audits carried out by our clients or subcontracted manufacturers and give support in the Inspections of regulatory authorities.
• Participate in the implementation and improvement of the quality of the company and subcontractors.