DPS Group Global
Documentation Specialist
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Documentation & Compliance Specialist - Kerry
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
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.
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Essential Qualifications & Experience
- Strong technical writing skills and close attention to detail.
- Comfort working across QMS/document management systems and change-control processes.
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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.
Arcadis is an Equal Opportunities Employer.
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