Quality Assurance Specialist

hace 2 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.

Job Summary

The External QA Specialist will be responsible for maintaining and improving an effective and efficient quality assurance system that ensures compliance with current regulations, including GMP, GDP, and ICH Quality guidelines. This role will guarantee that medicinal products manufactured by external contract manufacturing organizations (CMOs) are consistently produced, tested, and distributed in accordance with quality standards.

Key Responsibilities
  • Write, review, approve, and monitor CAPAs, deviations, OOS, complaints, and change controls.
  • Write, execute, or review validation activities related to storage and distribution.
  • Write, execute, or review qualifications (equipment, utilities, and facilities) and validations (e.g., process, cleaning).
  • Write, review, and approve Product Quality Review reports.
  • Perform Compliance checks (internal procedures vs. filed documentation).
  • Execute internal and external audits. Attend audits from Health Authorities and customers.
  • Prepare and execute GMP trainings.
  • Attend requests regarding quality related to marketed products.
  • Supervise the quality of the product in the market and drive continuous improvement.
  • Support the assigned Product Lifecycle projects.
  • Supervise 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.
  • Key Capabilities: Analytical thinking, and team player mentality, with organizational and prioritization skills.
  • Availability to travel.
What 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.
  • Temporary contract of 1 year.
  • A specialized team focused on our core activity: Improving our patients' lives.


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About NeuraxpharmNeuraxpharm 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...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About NeuraxpharmNeuraxpharm 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...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About NeuraxpharmNeuraxpharm 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...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About NeuraxpharmNeuraxpharm 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...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About NeuraxpharmNeuraxpharm 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...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About NeuraxpharmNeuraxpharm 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...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About Neuraxpharm Group Neuraxpharm stands as a premier European specialty pharmaceutical organization dedicated to addressing central nervous system (CNS) disorders, encompassing both psychiatric and neurological conditions. With over 35 years of expertise, the company possesses a profound understanding of the CNS market. Constantly innovating,...

  • Quality Assurance Expert

    hace 2 semanas


    Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About Neuraxpharm Group Neuraxpharm stands as a premier European specialty pharmaceutical organization dedicated to addressing central nervous system (CNS) disorders, encompassing both psychiatric and neurological conditions. With over 35 years of expertise, the company possesses a profound understanding of the CNS market. Constantly innovating,...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About Neuraxpharm Group Neuraxpharm stands as the premier European specialty pharmaceutical entity dedicated to addressing central nervous system (CNS) conditions, encompassing both psychiatric and neurological ailments. With over 35 years of expertise, the company possesses a profound comprehension of the CNS landscape. Constantly at the forefront of...

  • Quality Assurance Expert

    hace 2 semanas


    Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About Neuraxpharm Group Neuraxpharm stands as the premier European specialty pharmaceutical entity dedicated to addressing central nervous system (CNS) conditions, encompassing both psychiatric and neurological ailments. With over 35 years of expertise, the company possesses a profound comprehension of the CNS landscape. Constantly at the forefront of...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About Neuraxpharm Group Neuraxpharm stands as a premier European specialty pharmaceutical organization dedicated to addressing central nervous system (CNS) disorders, encompassing both psychiatric and neurological conditions. With over 35 years of expertise, the company possesses a profound understanding of the CNS market. Constantly pushing the...

  • Quality Assurance Expert

    hace 2 semanas


    Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    About Neuraxpharm Group Neuraxpharm stands as a premier European specialty pharmaceutical organization dedicated to addressing central nervous system (CNS) disorders, encompassing both psychiatric and neurological conditions. With over 35 years of expertise, the company possesses a profound understanding of the CNS market. Constantly pushing the...


  • Sant Cugat, Barcelona, España Formel D GmbH A tiempo completo

    **About Formel D GmbH**We are a global service provider within the automotive industry, dedicated to developing market-leading concepts and individual, scalable solutions along the entire value chain – from development to production to aftersales.Our company was founded in 1993, and our headquarters is located in the metropolis of Cologne. Today, more than...


  • Sant Cugat, Barcelona, España Formel D GmbH A tiempo completo

    **About Formel D GmbH**We are a global service provider within the automotive industry, dedicated to developing market-leading concepts and individual, scalable solutions along the entire value chain – from development to production to aftersales.Our company was founded in 1993, and our headquarters is located in the metropolis of Cologne. Today, more than...


  • Sant Cugat, Barcelona, España Formel D GmbH A tiempo completo

    {"h1": "Quality Engineer Position at Formel D GmbH", "p": "At Formel D GmbH, we are seeking a skilled Quality Engineer to join our team in the Barcelona area. As a Quality Engineer, you will play a crucial role in ensuring the quality of our products and services, adhering to industry standards and regulations such as VDA and ISO 9001.Responsibilities:*...


  • Sant Cugat, Barcelona, España Formel D GmbH A tiempo completo

    {"h1": "Quality Engineer Position at Formel D GmbH", "p": "At Formel D GmbH, we are seeking a skilled Quality Engineer to join our team in the Barcelona area. As a Quality Engineer, you will play a crucial role in ensuring the quality of our products and services, adhering to industry standards and regulations such as VDA and ISO 9001.Responsibilities:*...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    Job Title: Quality Control Specialist - External Manufacturing ManagementWe are seeking a highly skilled Quality Control Specialist to join our team at Neuraxpharm. As a Quality Control Specialist, you will be responsible for evaluating and assessing analytical instructions for Raw Materials, Semi-finished products, and Pharmaceutical Finished products.Key...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    Job Title: Quality Control Specialist - External Manufacturing ManagementWe are seeking a highly skilled Quality Control Specialist to join our team at Neuraxpharm. As a Quality Control Specialist, you will be responsible for evaluating and assessing analytical instructions for Raw Materials, Semi-finished products, and Pharmaceutical Finished products.Key...


  • Sant Cugat, Barcelona, España Grifols A tiempo completo

    About GrifolsGrifols is a global healthcare company dedicated to improving the health and well-being of people around the world. With a rich history dating back to 1909, we have established ourselves as leaders in plasma-derived medicines and transfusion medicine.Job SummaryWe are seeking a highly skilled Pharmacovigilance QA Specialist to join our Clinical...


  • Sant Cugat, Barcelona, España Grifols A tiempo completo

    About GrifolsGrifols is a global healthcare company dedicated to improving the health and well-being of people around the world. With a rich history dating back to 1909, we have established ourselves as leaders in plasma-derived medicines and transfusion medicine.Job SummaryWe are seeking a highly skilled Pharmacovigilance QA Specialist to join our Clinical...