Quality Control Specialist

hace 3 semanas

Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

Job Title: Quality Control Specialist

About the Role:

We are seeking a highly skilled Quality Control Specialist to join our team at Neuraxpharm. 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 for active pharmaceutical ingredients and finished dosage forms from CMOs/CROs.
  • Revision of Analytical Method Transfer Protocols & Reports for corresponding analytical methods for active pharmaceutical ingredients and finished dosage forms between Sending unit CMO and Receiving unit CMO.
  • Writing of technical reports and SOPs (Standards Operating Procedures).
  • Collecting Analytical methods from CMOs (Sending unit – Receiving unit) and filing into NxP QMS system.
  • Management and review of documentation provided by CROs and CMOs in reference to analytical validations & transfers activities according to different markets (FDA, US, ANVISA, EUR).
  • Management of all material needed to complete activities.
  • Follow-up of experimental work of the CMO, as well as review of raw data generated by them.
  • Acting as an interlocutor between the transferring laboratory and receiving laboratory.
  • Support to Regulatory Affairs team to answer deficiency letters from agencies or to clients' queries in life cycle management projects to get the dossier approval.

Requirements:

  • Bachelor's degree in pharmacy or chemistry.
  • Experience minimum demonstrable of 1-2 years as technology transfer in Quality Control of a pharmaceutical company.
  • Extensive knowledge of basic and specific manufacturing and analytical methods for pharmaceutical products: Analytical Method Transfer / Validation, ICH stability guidelines, GMP Guidelines, Change Control procedures and good understanding of the Variation Guideline.
  • Intermediate level of English and Spanish.
  • Specific Knowledge: Quality Systems: GMPs, GLPs, Pharmacopoeia, ICH regulations and Office tools (MS Office) and LIMS and SAP software.
  • Key Capabilities: Analytical thinking, and Quality oriented, with 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. It has a unique understanding of the CNS market built over 35 years.

Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.

The company has c. 1,000 employees and develops and commercializes 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.

Neuraxpharm manufactures many of its 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 the 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, a dynamic, a result-focused and an expert & excellent team.

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