Quality Assurance Specialist

hace 3 días

Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

About Neuraxpharm

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. With a unique understanding of the CNS market built over 35 years, the company is constantly innovating, with new products and solutions to address unmet patient needs.

The Quality Assurance Specialist will play a crucial role in providing confidence that quality requirements are fulfilled. This involves ensuring the compliance with Good Manufacturing Practice as part of Quality Management, which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.

The key responsibilities of this role include:

  • Writing, reviewing, or approving technical documents, such as SOPs, master and batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, utilities monitoring, environmental conditions, etc.
  • Preparing and executing GMP trainings.
  • Compliance with internal procedures versus filed documentation.
  • Writing and monitoring CAPAs, deviations, and change controls.
  • Writing and reviewing Product Quality Review reports.
  • Planning, reviewing, and approving calibration activities.
  • Executing internal and external audits, attending audits from Health Authorities and customers.
  • Attending requests related to marketed products regarding quality, administration, and storage.
  • Participating in assigned projects.

Requirements

  • 2-5 years of experience in a Quality Assurance Department.
  • Bachelor's or Master's degree in Pharmacy, Life Sciences, Engineering, or Chemistry studies.
  • Proficient level of English and Spanish.
  • Specific knowledge: GMP, Quality Management System, IT: Office, SAP, LIMS.
  • QP experience is valuable.
  • Key capabilities: analytical thinking, team player mentality, organizational, and prioritization skills.

We Offer

  • Individual professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
  • Economic conditions according to experience and skills provided.
  • A motivated and committed environment based on a diverse and inclusive culture.
  • A specialized team focused on our core activity: Improving our patients' lives.

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