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 company has more than 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, and globally via partners in over 60 countries. Neuraxpharm is backed by funds advised by Permira.

We are seeking a Quality Assurance Specialist to maintain and improve an effective and efficient quality assurance system that ensures compliance with current regulations, including GMP, GDP, and ICH Quality guidelines.

The successful candidate will be responsible for:

  • Writing, reviewing, approving, and monitoring CAPAs, deviations, OOS, complaints, and change controls.
  • Writing, executing, or reviewing validation activities related to storage and distribution.
  • Writing, executing, or reviewing qualifications (equipment, utilities, and facilities) and validations (e.g., process, cleaning).
  • Writing, reviewing, and approving Product Quality Review reports.
  • Performing Compliance checks (internal procedures vs. filed documentation).
  • Executing internal and external audits. Attending audits from Health Authorities and customers.
  • Preparing and executing GMP trainings.
  • Attending requests regarding quality related to marketed products.
  • Supervising the quality of the product in the market and driving continuous improvement.
  • Supporting the assigned Product Lifecycle projects.
  • Supervising activities of the MAHs and Distributors.
  • Supplier qualification management.

Requirements

  • +2 years of experience in a Quality Assurance Department, some knowledge in transport audit. Bachelor's or Master's degree (ended or in process of) 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, and team player mentality, with organizational and prioritization skills.
  • Availability to travel.

We Offer

  • Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
  • Economic conditions will be according to the 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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