Analytical Quality Control Specialist

hace 2 semanas

Barcelona, Barcelona, España Neuraxpharm A tiempo completo

Job Summary

We are seeking an experienced Analytical Quality Control Specialist to join our team at Neuraxpharm. As a key member of our External Manufacturing Management department, you will be responsible for ensuring the quality and compliance of our analytical methods and processes.

Key Responsibilities:

  • Review and revise analytical method validation protocols and reports for active pharmaceutical ingredients and finished dosage forms from Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs).
  • Provide technical support for the development and implementation of analytical method transfer protocols and reports between CMOs.
  • Write and approve technical documentation, including SOPs and technical reports, in accordance with current quality regulations.
  • Manage and review documentation provided by CROs and CMOs, including analytical validations and transfers, for various markets (FDA, US, ANVISA, EUR).
  • Oversee the collection and filing of analytical methods in our Quality Management System (QMS).
  • Ensure compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to ensure seamless execution of analytical transfer programs and projects.

Requirements:

  • Strong background in analytical quality control and regulatory compliance.
  • Experience with analytical method validation and transfer.
  • Excellent communication and technical writing skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Strong attention to detail and organizational skills.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

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