Documentation Specialist

DPS Group Global; Munster; On-site; EUR 45,000 - 60,000; Full time

Job summary

DPS Group Global is seeking a Documentation & Compliance Specialist in Kerry, Ireland. The role focuses on managing the Technology Transfer/NPI document suite and the compliance framework to ensure transfer packages are controlled, traceable and right-first-time through approvals.

The ideal candidate has 2+ years' experience in GMP documentation control or related quality systems within pharma or life sciences.

Qualifications

• 2+ years' experience in GMP documentation control, quality systems or technical writing.
• Experience with EU GMP Annex 1 (2022) documentation expectations for sterile manufacturing (preferred).
• Experience supporting transfer, NPI or validation programmes is advantageous.

Responsibilities

• Own the TT document suite using site templates and numbering conventions.
• Coordinate change control, document approval routing and transfer-package traceability.
• Maintain transfer tracker/dashboard and support programme reporting to Tech Transfer/NPI Lead.
• Support document readiness reviews ahead of transfer phases.
• Act as the function's point of contact for internal audit and inspection readiness.

Skills

GMP documentation control

Quality systems

Technical writing

Change-control processes

Audit readiness

Tools

QMS / 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.
• 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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