Technical Writer

• Author, review and update IT SOPs, work instructions, qualification documentation and templates
• Cover IT change and release management, incident/problem/service request management, backup/restore/archiving, business continuity/disaster recovery, patch/vulnerability management, configuration management, audit trail review, and IT supplier/cloud service provider management
• Ensure IT procedures meet 21 CFR Part 11, EU GMP Annex 11, MHRA GxP Data Integrity Guidance and GAMP 5 expectations
• Document controls that keep GxP systems validated across commissioning, periodic review, decommissioning and data migration
• Apply ALCOA+ principles to electronic records, signatures, audit trails and system administration procedures
• Align IT SOPs with ITIL-based service management and ITSM tooling such as ServiceNow
• Document information-security controls aligned with ISO 27001, NIST CSF or Cyber Essentials
• Manage documents through the EDMS lifecycle, including drafting, review routing, approval, effective dating, periodic review and retirement
• Harmonise legacy IT documentation and separate GxP from non-GxP scope
• Support regulatory, internal and supplier audits by preparing document packs and responding to queries
• Work with Training to ensure IT staff are trained on new and revised SOPs and training records are maintained