QA Manufacturing Liaison — Batch Release & Documentation

AGC Biologics, Inc.; København; In loco; DKK 420.000 - 660.000; Tempo pieno

Descrizione del lavoro

AGC Biologics, Inc. seeks a QA Manufacturing Support Technician in Søborg, Denmark, to join a close partnership between Quality and Manufacturing.

You will support solution preparation, review batch records and buffer/media docs to ensure GMP compliance, and act as a bridge between QA and production on the floor. The role combines hands-on production involvement with meticulous documentation tasks, contributing to smooth batch release and adherence to GMP/GLP standards.

Competenze

• Experience in GMP or GLP production environment is preferred.
• Familiar with reviewing Batch Production Records (BPR) and Solution Preparation Sheets.
• Knowledge of Good Documentation Practice (GDP) is advantageous.

Mansioni

• QA Oversight in the Solution Preparation production suite.
• Reviewing and approving Batch Production Records for Buffer and Media.
• Print Batch Process Records and manage manufacturing labels.
• Provide real-time review of manufacturing records and logbooks.
• Support scanning, archiving and related activities as needed.

Conoscenze

Strong communication

Collaboration

English fluency

Formazione

Bachelor's degree (BSc) or Technician in production

Descrizione del lavoro

AGC Biologics, Inc. seeks a QA Manufacturing Support Technician in Søborg, Denmark, to join a close partnership between Quality and Manufacturing.

You will support solution preparation, review batch records and buffer/media docs to ensure GMP compliance, and act as a bridge between QA and production on the floor. The role combines hands-on production involvement with meticulous documentation tasks, contributing to smooth batch release and adherence to GMP/GLP standards.