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.
...
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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