Documentation Specialist

The successful Documentation Specialist will manage the Technology Transfer/NPI document suite and compliance framework, ensuring every transfer package is controlled, traceable and right-first-time through approval.Experience (ideally 2+ years) in GMP documentation control, quality systems or technical writing within a pharmaceutical or life sciences environment.

Key Responsibilities

• Own the TT document suite (Transfer Plans, protocols, reports) using the site's controlled templates and numbering conventions.
• Coordinate change control, document approval routing, and transfer-package traceability back to source (sending-site) documentation.
• Maintain the transfer tracker/dashboard and support programme reporting to the Tech Transfer/NPI Lead.
• Support document readiness reviews ahead of each transfer phase-gate.
• Act as the function's point of contact for internal audit and inspection readiness relating to transfer documentation.
• Essential Qualifications & Experience
• Strong technical writing skills and close attention to detail.
• Comfort working across QMS/document management systems and change-control processes.

Desirable

• Experience supporting a technology transfer, NPI or validation programme specifically (rather than documentation control in general).
• Familiarity with EU GMP Annex 1 (2022) documentation expectations for sterile manufacturing.
• Experience building or adapting a document suite for a new function or programme.