Quality Control Specialist

hace 7 días

Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo
Job Title: Quality Control Specialist - External Manufacturing Management

Neuraxpharm is seeking a highly skilled Quality Control Specialist to join our team in Sant Joan Despí, Barcelona. As a Quality Control Specialist, you will be responsible for the evaluation and assessment of analytical instructions for Raw Materials, Semi-finished products, and Pharmaceutical Finished products.

Key Responsibilities:
  • Revision of Analytical Method Validation Protocols & Reports for new analytical methods.
  • Revision of Analytical Method Transfer Protocols & Reports for corresponding analytical methods.
  • Writing of technical reports and SOPs.
  • Management and review of documentation provided by CROs and CMOs.
  • Management of all material needed to complete activities.
  • Follow-up of experimental work and review of raw data generated by CMOs.
  • Act as an interlocutor between transferring and receiving laboratories.
  • Support to Regulatory Affairs team to answer deficiency letters and client queries.
  • Evaluation and improvement of analytical methods based on experience and analytical issues.
Requirements:
  • Bachelor's degree in pharmacy or chemistry.
  • Minimum 1-2 years of experience as Technology Transfer in Quality Control of a pharmaceutical company.
  • Extensive knowledge of basic and specific manufacturing and analytical methods for pharmaceutical products.
  • Intermediate level of English and Spanish.
  • Specific knowledge of Quality Systems, GMPs, GLPs, Pharmacopoeia, ICH regulations, and Office tools.
  • Key capabilities: analytical thinking, quality oriented, organizational, and prioritization skills.
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. We have a unique understanding of the CNS market built over 35 years.

We are constantly innovating, with new products and solutions to address unmet patient needs and are expanding our portfolio through our pipeline and acquisitions.

We have c. 1,000 employees and develop and commercialize CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, and globally via partners in more than 40 countries. Neuraxpharm is backed by funds advised by Permira.

We manufacture many of our pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.

What We Offer:
  • Individual professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
  • Attractive remuneration according to experience and skills provided.
  • An inspiring leadership team that drives performance.
  • An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, dynamic, result-focused, and expert & excellent team.

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