GMP Documentation Analyst

hace 6 días

Mar del Plata, Buenos Aires, Argentina Mantell Associates A tiempo completo

Mantell Associates is partnered with a global biosimilars CDMO, who is seeking a detail-oriented GMP Documentation Analyst to join their Quality team on a contract basis at their Buenos Aires site.

This is an excellent opportunity to join a globally recognized biosimilars CDMO and play a critical role in ensuring regulatory compliance and documentation excellence within a high-performance Quality environment.

GMP Documentation Analyst - Responsibilities:

  • Review, modify, and manage GMP documentation, including SOPs, Batch Records, QC data, and regulatory documentation
  • Support Quality Assurance activities, including Change Controls, CAPAs, and Quality Event management
  • Assist with report generation and documentation related to product releases and compliance audits
  • Ensure all documentation is complete, accurate, and compliant with internal procedures and current cGMP requirements
  • Maintain document control systems and ensure proper version control and archival processes
  • Support preparation for internal and external audits and regulatory inspections by ensuring documentation readiness and compliance
  • Collaborate cross-functionally with Manufacturing, QC, and QA teams to ensure alignment on documentation standards and timelines

GMP Documentation Analyst - Requirements:

  • Proven experience in GMP documentation support within a pharmaceutical, biologics, or biotechnology manufacturing environment
  • Familiarity with Quality systems such as TrackWise or equivalent electronic Quality Management Systems (eQMS)
  • Strong understanding of regulatory requirements and GMP compliance standards
  • High level of attention to detail with the ability to manage multiple documentation tasks simultaneously
  • Strong organizational and communication skills with a proactive approach to problem solving
  • Availability to work on-site in Buenos Aires, 5 days per week

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us

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