Documentation Specialist

DPS Group Global; Munster; On-site; EUR 40,000 - 60,000; Full time

Job summary

DPS Group Global in Kerry is seeking a Documentation & Compliance Specialist to manage the technology transfer document suite and ensure compliant, right-first-time transfer packages.

The role requires 2+ years' GMP documentation control or quality systems experience, with strong technical writing and attention to detail. You will coordinate change control and support audit readiness within the TT/NPI framework.

Qualifications

• 2+ years of GMP documentation control experience.
• Experience with quality systems or technical writing in life sciences.
• Strong technical writing skills with close attention to detail.

Responsibilities

• Own the TT document suite (Transfer Plans, protocols, reports) using controlled templates.
• Coordinate change control, document approval routing, and transfer-package traceability to source documentation.
• Maintain transfer tracker/dashboard and support reporting to Tech Transfer/NPI Lead.
• Support document readiness reviews ahead of each transfer phase-gate.
• Act as point of contact for internal audit and inspection readiness related to transfer documentation.

Skills

Technical writing

Attention to detail

QMS familiarity

Document management

Tools

Document management systems

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.