Quality Assurance Specialist

hace 1 día

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.

Job Summary

We are seeking a Quality Assurance Specialist to join our team in Sant Joan Despí. As a key member of our Quality Assurance Department, you will be responsible for providing confidence that quality requirements are fulfilled, ensuring compliance with Good Manufacturing Practice as part of our Quality Management system.

Key Responsibilities
  • Write, review, or approve technical documents, including SOPs, master and batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, utilities monitoring, and environmental conditions.
  • Write, execute, or review qualifications (equipment, utilities, and facilities) and validations (process, cleaning, IT, and utilities).
  • Prepare and execute GMP trainings.
  • Ensure compliance with internal procedures versus filed documentation.
  • Write and monitor CAPAs, deviations, and change controls.
  • Write and review Product Quality Review reports.
  • Plan, review, and approve calibration activities.
  • Execute internal and external audits, attending audits from Health Authorities and customers.
  • Support customer queries about assigned products.
  • Manage assigned I+D 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 of GMP, Quality Management System, IT (Office, SAP, LIMS).
  • QP experience is valuable.
  • Key capabilities: analytical thinking, team player mentality, organizational, and prioritization skills.
What 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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