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.
Recruitment Agencies: Please do not reply to this job advert.
Seniority level
Mid-Senior level
Employment type
Contract
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Manufacturing
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