Documentation Controller - 12 Month Contract
Core
Manage and maintain site documentation systems, ensuring compliance with quality, regulatory, and operational requirements while supporting inspection readiness.
Role type
Documentation Controller
Builds
Controlled documentation, batch records, validation documentation, and archiving systems
Domain
Pharmaceutical/Manufacturing compliance
Required skills
Document management systems, Microsoft Office, document auditing, change control, batch record management, validation documentation, EHS&E compliance, metrics reporting, cross-functional collaboration
Preferred skills
Experience in document control/quality/compliance, technical documentation management, pharmaceutical/medical device/biotechnology/manufacturing industry experience
Responsibilities
Receive and manage documents from the Global Documentation Management System, Generate, update, maintain, and issue internal controlled documentation, Manage and control changes to documented procedures, Conduct documentation audits, Issue and manage batch record documentation, Control the storage and archiving of completed batch records, Maintain validation and engineering/process validation documentation, Process and manage document change requests, Support and comply with all EHS&E standards, Provide support and administration for the Document Centre Helpdesk, Support regulatory inspection and PAI readiness activities, Compile, analyse, and report departmental metrics and KPI data, Collaborate with cross-functional teams to ensure document control processes meet compliance requirements, Drive continuous improvement initiatives related to documentation management