Documentation Specialist

DPS Group

Munster

On-site

EUR 42,000 - 63,000

Full time

5 days ago
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Job summary

DPS Group in Kerry, Ireland is seeking a Documentation & Compliance Specialist to manage the TT document suite and ensure a controlled, right-first-time transfer process within a GMP framework.

You will coordinate change control, maintain trackers, and support audit readiness across transfer documentation for new product introductions and technology transfers.

Qualifications

  • 2+ years in GMP documentation control, quality systems or technical writing.
  • Experience in pharmaceutical or life sciences documentation environments.
  • Strong technical writing and close attention to detail.

Responsibilities

  • Own the TT document suite (Transfer Plans, protocols, reports) using controlled templates and numbering.
  • Coordinate change control, document approval routing, and transfer-package traceability back to source docs.
  • 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.

Skills

Technical writing
Attention to detail
QMS
Change control
Documentation management

Tools

QMS software
Document management systems
Change-control processes

Job description

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 (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.

Arcadis is an Equal Opportunities Employer.

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