BMR Reviewer Specialist
Core
Review Batch Manufacturing Records (BMRs) for accuracy and GMP compliance in a 24/7 rotating shift manufacturing environment.
Role type
Batch Record Reviewer Specialist
Builds
Production documentation and batch records for pharmaceutical/biopharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (documentation review)
Required skills
GMP principles, batch record review, documentation error identification, SAP proficiency, EDMS usage, change control management, CAPA support, training delivery, practical process improvement
Preferred skills
sterile filtration experience, deviation investigations, Lean methodologies, SOP authoring
Technologies
SAP, Electronic Document Management System (EDMS), Microsoft Office
Responsibilities
Review BMRs for accuracy and compliance; Identify and trend documentation errors; Track batch record review progress; Ensure timely closure of batch steps in SAP; Draft and maintain Master Batch Records; Author and review SOPs and risk assessments; Coordinate investigations and implement CAPA; Manage change controls for BMRs; Provide training on good documentation practices; Apply process improvement tools.
Seniority
Individual Contributor, operational level
