GMP QA Specialist: QC Lab & Data Integrity

3Pbiovian; Navarra; Presencial; EUR 45.000 - 65.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

26 paid days off

Flexible compensation plan

Wellbeing programs

Career growth opportunities

Descripción de la vacante

3PBiovian is seeking a QA Specialist (QC Laboratory) to join the Quality Assurance Team in Navarra. You will act as QA representative in the QC lab, provide on-the-floor QA support, and ensure GMP compliance across laboratory activities.

Your responsibilities include reviewing analytical documentation, ensuring data integrity, and participating in deviation investigations, CAPA and SOP improvements. Strong knowledge of LIMS and analytical platforms is essential, with fluency in Spanish and

Formación

• Bachelor’s degree in a relevant scientific discipline and GMP experience.
• Minimum 4 years in QA, QC or equivalent in GMP environments.
• Experience with raw data review, deviations, CAPA and GMP docs.
• Knowledge of ALCOA+/ALCOA++ data integrity principles.
• Familiarity with EU GMP Annex 11, 21 CFR Part 11 and GAMP 5 is preferred.
• Experience with LIMS, Empower 3 and Gen 5 is highly valued.
• Spanish fluency and English at least B2/C1.

Responsabilidades

• Act as Quality Assurance representative within the QC laboratory.
• Provide on-the-floor QA support and promote GMP practices.
• Review analytical documentation, records, calculations, chromatograms and raw data.
• Ensure data integrity and traceability of electronic and paper records.
• Oversee use of laboratory systems and equipment for QA compliance.
• Review access controls, audit trails, backups and archiving processes.
• Participate in deviation investigations, root cause analysis and CAPA.
• Prepare and improve SOPs related to QC, Data Integrity and audits.
• Support qualification and training of lab personnel in GMP principles.
• Support analytical method validation and transfer activities.

Conocimientos

GMP knowledge

Data integrity

QA documentation review

On-the-floor QA support

Quality culture & compliance

English proficiency (B2/C1)

Educación

Bachelor’s degree in Chemistry, Biotechnology, Biology, Biochemistry, Pharmacy

Master’s or postgraduate in Quality, CSV or Data Integrity (asset)

Herramientas

LIMS

Empower 3

Gen 5

Descripción del empleo

3PBiovian is seeking a QA Specialist (QC Laboratory) to join the Quality Assurance Team in Navarra. You will act as QA representative in the QC lab, provide on-the-floor QA support, and ensure GMP compliance across laboratory activities.

Your responsibilities include reviewing analytical documentation, ensuring data integrity, and participating in deviation investigations, CAPA and SOP improvements. Strong knowledge of LIMS and analytical platforms is essential, with fluency in Spanish and