GMP QA Specialist – QC Lab & Data Integrity

3PBIOVIAN

Noáin

Presencial

EUR 52.000 - 64.000

Jornada completa

hace 46 horas
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Ventajas ofrecidas por este puesto de trabajo

26 paid days off
Flexible compensation plan
Relocation assistance
Well-being programs
Career development

Descripción de la vacante

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

The role requires at least 4 years in QA/QC in GMP environments, experience with data integrity, raw data review and deviation investigations, plus proficiency with LIMS, Empower 3 and Gen 5. A Bachelor’s in a related science is required.

Formación

  • Bachelor’s degree in Chemistry, Biotechnology, Biology, Biochemistry, Pharmacy or related scientific discipline.
  • Minimum 4 years of QA/QC in GMP-regulated pharma/biotech environments.
  • Experience with raw data review, deviation investigations and CAPA management.
  • Knowledge of GMP, Good Documentation Practices and Data Integrity.

Responsabilidades

  • Act as QA representative within the QC laboratory, ensuring GMP compliance.
  • Provide on-the-floor QA support and promote GMP and documentation best practices.
  • Review analytical documentation, records, chromatograms and raw data for accuracy.
  • Ensure data integrity per ALCOA+/ALCOA++ principles and secure records.

Conocimientos

QA
GMP
Data Integrity
Documentation
On-the-floor QA

Educación

Bachelor’s degree in Chemistry/related
Master’s degree asset

Herramientas

LIMS
Empower 3
Gen 5

Descripción del empleo

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

The role requires at least 4 years in QA/QC in GMP environments, experience with data integrity, raw data review and deviation investigations, plus proficiency with LIMS, Empower 3 and Gen 5. A Bachelor’s in a related science is required.

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