Job Description

Job Title: GMP Manufacturing Documentation SpecialistJob Description
We are seeking a GMP Manufacturing Documentation Specialist to support multiple technical transfer projects for sterile injectable pharmaceutical products. This role entails authoring, revising, coordinating, and driving approval of GMP manufacturing documentation, with a primary focus on Master Batch Records (MBRs) and related controlled manufacturing documents.
Responsibilities

+ Author, revise, and coordinate GMP manufacturing documentation.

+ Drive approval of Master Batch Records and related controlled documents.

+ Collaborate with cross-functional Subject Matter Experts (SMEs) to gather technical information.

+ Translate manufacturing processes into compliant documentation.

+ Coordinate document reviews and reconcile reviewer comments.

+ Facilitate review meetings and drive documentation through the approval process until implementation-ready.

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