GMP Documentation Analyst

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 at +44 (0)20 3854 7700.

Tagged as: Quality