GMP Batch Documentation Specialist (m/f/d)
On-site
Core
Review batch records for compliance with ALCOA+ and GDP principles in a biopharma biologics manufacturing environment.
Role type
Junior batch record reviewer (GMP documentation)
Builds
GMP-compliant batch records and documentation for biologics production
Domain
Biopharmaceuticals / Life Sciences
Required skills
GMP compliance knowledge, GDP principles, batch record review, material tracking, deviation management, electronic batch record (EBR) systems
Preferred skills
Biologics manufacturing experience, Life Sciences degree
Technologies
COMET, SAP
Responsibilities
Review batch protocols for ALCOA+ and GDP compliance, verify PI-sheets and BOMs for material tracking, identify documentation gaps and coordinate corrections, support creation of batch record templates, assist with deviations and investigations
Seniority
Junior, entry-level
